Adequacy of Dialysis and Nutrition in Continuous

Peritoneal Dialysis: Association with Clinical Outcomes1

CANADA-USA (CANUSA) Peritoneal Dialysis Study Group2’3

was increased with decreased albumin concentra-

Principal Investigators: David N. Churchill, D. Wayne tion and decreased CCr. Hospitalization was in-
Taylor, Prakash R. Keshaviah creased with decreased serum albumin concentra-
tion, worsened nutrition according to subjective
Coordinating Center Investigators: Kevin E. Thorpe,
Mary Louise Beecroft
global assessment and decreased CCr. A weekly
Kt/V of 2. 1 and a weekly CCr of 70 L/ 1.73 m2 were
Clinical Center Investigators: Kailash K. Jindal. Stanley
each associated with an expected 2-yr survival of
S.A. Fenton, Joanne M. Bargman, Dimitrios G.
78%.
Oreopoulos. David N. Churchill, George G. Wu, Susan
D. Lavoie, Adrian Fine, Ellen Burgess. James C. Key Words: Clinical trial, urea, creatinine, multivariate, pa-
Brandes, Karl D. Nolph, Barbara F. Prowant. Denis tient survival
Page, Francis X. McCusker,
K. Dasgupta, Kelvin Bettcher,
Brendan P. Teehan,
Ralph Caruana
Mrinal
C ontinuous
(CAPD)
ambulatory
1 ,2) is the treatment
(
peritoneal
used
dialysis
for approxi-
Baxter Healthcare Investigators: George deVeber,
Lee W. Henderson mately 1 4% of the world’s dialysis population (3). With
adjustment for comorbidity, Burton and Walls (4) and
(J, Am. Soc. Nephrol. 1996; 7:198-207) the Canadian Organ Replacement Register (5) re-
ported no difference between CAPD and hemodialysis
with respect to patient survival. However, Maiorca et
ABSTRACT al. (6) found better survival for patients aged 53.5 yr
The objective of the study presented here was to and greater treated with CAPD while Held et a!. (7)
evaluate the relationship of adequacy of dialysis and reported an increased risk of death for older diabetic
nutritional status to mortality, technique failure, and patients treated with CAPD.
morbidity. This was a prospective cohort study of For patients treated with hemodialysis. longer dial-
consecutive patients commencing continuous perito- ysis times and better nutritional status are associated
neal dialysis in 14 centers in Canada and the United with better patient survival (8,9). Increased removal of
States. Between September 1 1990 and December31, ,
small molecular weight sobutes is associated with
1992, 680 patients were enrolled. Follow-up was termi- decreased morbidity ( 10). For patients treated with
CAPD, some data suggest an association between
nated December 31 1993. There were 90 deaths,
, 137
improved survival and better nutritional status
transplants, and 1 18 technique failures. Fifteen with-
( 1 1 1 2). There
, are conflicting reports regarding the
drew from dialysis. Analysis of the patient and tech- relationship between estimates of adequacy of dialysis
nique survival used the Cox proportional hazards and clinical outcomes ( 13-18). The methodobogic lim-
model with adequacy of dialysis and nutritional status itations of these studies include small sample size
as time-dependent covariates. The relative risk (PR) of with inadequate statistical power, insensitive clinical
death increased with increased age, insulin-depen- outcomes, and use of univariate rather than multiva-
dent diabetes mellitus, cardiovascular disease, de- nate statistical analysis (19).
creased serum albumin concentration and worsened In this article, we report the results of a multicenter
nutritional status (subjective global assessment and prospective cohort study of 680 patients commencing
continuous peritoneal dialysis in 14 centers in Can-
percentage lean body mass). A decrease of 0. 1 unit
ada and the United States between September 1 1990 .
Kt/V per week was associated with a 5% increase in
and December 3 1 1992, , with follow-up until Decem-
the RR of death; a decrease of 5 L/1 .73 m2 creatinine
ber 3 1 1993. , The objectives of the study were: (1 ) to
clearance (CCr) per week was associated with a 7% evaluate the association of adequacy of dialysis with
Increase In the RR of death. The RR oftechnique failure mortality. technique failure and hospitalization; and
(2) to evaluate the association of nutritional status
1 Received May 17, 1995. Accepted November 21, 1995.
with those same variables.
2 Appendix for participating invesligators and affiliated organizations.

3 correspondence to Dr. D. churchill, McMaster University, St. Joseph’s Hospital,

50 charlton Avenue East, Hamilton, Ontario, canada L8N 4A6. METHODS
104&6673/0702.0198$03.00/0
Journal of the American Society of Nephrology The clinical centers participating in the study, listed in
copyright © 1996 by the American Society of Nephrology order of number of patients entered, were Victoria General

198 Volume 7 . Number 2 . 1996

 Churchill et al

Hospital (Halifax, Nova Scotia); Toronto Western and Toronto was estimated as the average of renal creatinine and urea
General Divisions ofThe Toronto Hospital (Toronto, Ontario); clearance (CCr + Curea)/2 (28). The serum f32M estimations
St. Joseph’s Hospital (Hamilton. Ontario): Credit Valley Hos- were performed by a solid-phase time-resolved fluoroimmu-
pital (Mississaugua, Ontario); Ottawa Civic Hospital (Ottawa. noassay (DELFIA; Wallace Canada. Vaudreuil, Quebec) in
Ontario); St. Boniface Hospital (Winnipeg. Manitoba): Foot- two reference laboratories.
hills Hospital (Calgary, Alberta); Medical College of Wiscon- The clinical outcomes were mortality, technique failure,
sin (Milwaukee, Wisconsin); University of Missouri Medical and hospitalization. Technique failure was defined as trans-
Center (Columbia, Missouri); Ottawa General Hospital (Otta- fer to hemodialysis or to conventional intermittent peritoneal
wa, Ontario): Lankenau Hospital (Philadelphia, Pennsylva- dialysis. Hospitalizations for vascular access surgery. renal
nia): University of Alberta Hospital (Edmonton. Alberta): allograft nephrectomy, elective pretransplant assessment,
Medical College of Georgia (Augusta, Georgia). The Coordi- and renal transplantation were excluded from the analysis of
nating Center was the Department of Clinical Epidemiology the effect of adequacy of dialysis on hospitalization. The
and Biostatistics, McMaster University, Hamilton, Ontario. duration of follow-up and total number of days hospitalized
All patients commencing continuous peritoneal dialysis for were used to calculate days hospitalized per month of follow-
the first time between September 1 , 1990 and December 31, up.
1992 were eligible for the study. Exclusion criteria were: (1) Statistical analysis of patient mortality and technique
being unlikely to survive for at least 6 months; (2) elective failure used Andersen and Gill’s (29) extension to the Cox
living donor kidney transplant within 6 months; (3) planned proportional hazards model (30) with estimates of nutritional
move from the study center within 6 months; (4) positive status and adequacy of dialysis as time-dependent covari-
hepatitis B or HIV serology; (5) active systemic inflammatory ates (31,32). Events (e.g., death or technique failure) were
disease; or (6) failure to sign the informed consent form. The attributed to the level of nutrition or adequacy of dialysis
dialysis prescription was that prescribed by the individual recorded at the 6-month evaluation preceding the event.
patient’s physician. Changes were made for clinical indica- Transplantation, recovery of renal function, technique fail-
tions and without reference to the data recorded at the ure and loss to follow-up were censored observations for the
Coordinating Center. patient survival analysis. Death, transplantation. recovery of
The demographic data recorded at enrollment included renal function, and loss to follow-up were censored observa-
age. sex, race, functional status according to the Karnofsky tions for the technique survival analysis. All baseline demo-
score (20), underlying renal disease, insulin-dependent dia- graphic and clinical variables and baseline serum albumin
betes mellitus (IDDM). and history of cardiovascular disease concentrations were entered. Backward elimination removed
(CVD). CVD was defined as a history of previous myocardial nonsignificant variables. The three estimates of adequacy of
infarction, angina, amputation for vascular disease, or Class dialysis (Kt/V. CCr, and (32M) were each added separately to
III through IV congestive heart failure. this model. Three estimates of nutritional status (NPCR.
Estimates of nutritional status were obtained at enroll- SGA, and % LBM) were each added separately to a model
ment and every 6 months thereafter. If there was an acute containing the significant baseline demographic variables,
medical problem. this estimate was obtained 1 month after serum albumin concentration, and one estimate of adequacy
resolution ofthe problem. Serum albumin concentration was of dialysis. The likelihood ratio test (3 1 .33) was used to
determined by the bromcresol green method. The subjective determine whether or not the addition of a variable to a model
global assessment (SGA) of nutritional status was deter- added significantly to that model. The validity of the propor-
mined by using a modification of the method described by tional hazards assumption was considered for all variables
Baker et a!. and Detsky et al. (2 1 .22). This technique is remaining in the final models by examining the Schoenfeld
reliable and valid for ESRD patients treated with CAPD (23). residuals (34).
Four items were scored on a seven-point Likard-type scale, To further explore the effect of Kt/V and CCr on patient
with lower values representing worse nutritional status. survival, the expected survival time was determined for
These values were weight loss during the past 6 months, several theoretical Kt/V and CCr values. Survival curves
anorexia, subcutaneous fat, and muscle mass. These four were constructed from the fitted models (3 1 ) for weekly Kt/V
items were given subjective weights to produce a global values of 2.3, 2.1, 1.9, 1.7, and 1.5, and for weekly CCr
assessment. Scores of 1 to 2 represented severe malnutri- values of 95, 80, 70, 55, and 40 L/wk per 1 .73 m2. These
tion; 3 to 5, moderate to mild malnutrition; and 6 to 7, survival curves assume no change in the Kt/V and CCr
normal nutrition. The protein catabolic rate (PCR) was deter- values over follow-up time. Peritoneal and renal clearance
mined according to Randerson et at. (24) and normalized to were considered equivalent with decreases in renal function
standard body weight (total body water/0.58). Total body compensated by Increased peritoneal clearance.
water (V) was determined from the formula of Watson et at. A log-linear model was used to analyze the hospitalization
(25). Percentage of lean body mass 1% LBM] was determined data (35). The dependent variable was the number of days
from creatinine kinetics (26). hospitalized per month of follow-up. The baseline explana-
Adequacy of dialysis was estimated by measurement of tory variables were: country (Canada/United States); age at
total weekly Kt/V for urea, total weekly creatinine clearance enrollment; sex: race (Caucasian / non-Caucasian); Karnof-
(CCr), and serum beta-2-microglobulin (f32M]. Peritoneal Kt sky score (<80 or 80): renal disease: IDDM; and CVD. For
was estimated from 24-h dialysate urea excretion and the explanatory variables estimated at 6-month intervals during
serum urea concentration. Renal Kt was estimated from the the study. the weighted average was used. These variables
concurrent 24-h urine urea excretion. Peritoneal creatinine were serum albumin concentration, SGA. NPCR. % LBM,
clearance was estimated from the 24-h dialysate creatinine Kt/V, CCr, and serum f32M.
excretion and the serum creatinine concentration at the The sample-size calculation was made on the basis of the
completion of the collection. Dialysate creatinine excretion patient survival analysis. For the multivariate analysis. ap-
was corrected for glucose Interference by using a validated proximately ten events (death) per independent variable are
correction factor (27) determined for each clinical chemistry required to produce a model of reasonable accuracy (36).
laboratory. The renal contribution to creatinine clearance Given the ten independent variables to be evaluated, the

Journal of the American Society of Nephrology 199

Adequacy and Nutrition in CAPD

study population had to be large enough to experience about TABLE 2. Adequacy and nutritional status
100 deaths during the follow-up period. The patient enroll- (baseline)a
ment target was 700 patients, with follow-up extended until
the requisite number of events was accumulated. . 1st 3rd
Mean Median .
Quartile Quartile
RESULTS
Kt/V (weekly) 2.38 2.28 1.96 2.68
There were 680 patients enrolled in the study. There Kt/V renal 0.71 0.64 0.30 0.99
were 97.9% treated with CAPD and 2. 1% with contin- Kt/V peritoneal 1.67 1.61 1.37 1.89
uous cycling peritoneal dialysis (CCPD). The mean CCr (1/week per 83.0 78.8 63.8 98.0
and median daily prescribed instilled volumes were 1.73 m2)
7.7 and 8.0 L, respectively. The mean age was 54.3 yr. CCr renal 38.8 34.6 18.2 53.2
with a range of 18 to 82 yr. The distribution of CCr peritoneal 44.2 43.6 38.5 50.1
demographic and clinical factors is shown In Table 1. Serum 32M 22.5 21.0 16.0 27.0
The mean height was 1 .66 m, mean weight was 67.8 (mg/I)
kg, and mean body mass index was 24.6 kg per m2. Serum albumin 34.9 35.0 31.0 39.0
The baseline values for adequacy of dialysis and nu- (g/L)
tritional status are shown in Table 2. By SGA assess- NPCR (g/kg) 1.04 1.01 0.87 1.19
ment, there were 30 patients (4.2%) with severe mal- SGA (1-7) 5.19 5.00 4.00 6.00
nutrition, 364 (5 1 .2%) with mild to moderate % IBM 62.6 60.9 53.3 71.0
malnutrition, and 3 1 7 (44.6%) considered well flour-
a Kt/V. for urea; OCr. creatinine clearance rate; NPCR, normalized
ished. protein catabolic rate; SGA, subjective global assessment; LBM, lean
body mass.

TABLE 1 Demographic
. and clinical factorsa
TABLE 3. Weekly mean Kt/V, CCr, and estimates of
Factor N (%) nutritional status

Race Follow-Up (Months) 0 6 12 18 24

Caucasian 558 82.1
African American 57 8.4 N 680 525 321 166 78
Asian 38 5.6 Kt/V 2.38 2.25 2.10 2.02 1.99a
Aboriginal 20 2.9 Peritoneal 1.67 1.67 1 .68 1.66 1.70
Other 7 1.0 Renal 0.71 0.58 0.41 0.39 0.28#{176}
Education CCr (1.73 m2) 83.0 74.7 68.3 65.7 61.6#{176}
<High school 315 46.3 Peritoneal 44.2 44.6 46.4 45.3 473b

High school 187 27.5 Renal 38.8 30.1 21.9 20.4 14.3#{176}
Technical 79 11.6 Nutrition
College/university 99 14.6 35.1 35.2
Serum albumin 34.9 35.1 35.1
Karnofsky Score (g/L)
80-100 399 58.7 NPCR (g/Kg/day) 1.04 1.03 0.97 0.96 0.99
50-70 268 39.4 SGA (0-7) 5.19 5.96 6.00 6.00 601b
<50 13 1.9 % IBM 62.6 63.3 63.5 63.1 65.3
Gender
a p < o.ooooi . baseline versus 24 months (paired t test).
Male 394 57.9 b p < 0.005. baseline versus 24 months (paired t test).
Female 286 42.1
Renal Disease
Diabetes 202 29.7 The changes In adequacy of dialysis and nutritional
Glomerulonephritis 160 23.5 status are shown In Table 3. The decrease in patient
Nephrosclerosis 95 14.0 numbers is partly because of death, transfer to hemo-
Renal vascular disease 42 6.2 dialysis, and transplantation. but also reflects the
Polycystic kidney 47 6.9 staggered entry of patients over the study period. For
disease total weekly Kt/V, there is a progressive decrease from
Other 134 19.7 2.38 to 1 .99. This decrease is entirely the result of loss
Comorbidity of the renal component. which decreases from 0.71 to
IDDM 151 22.2 0.28 whereas the peritoneal component remains sta-
CHF(111 orlV) 156 22.9 ble at 1 .67 to 1 .70. For total weekly CCr, there is a
Ml 99 14.6 progressive decrease from 83.0 to 6 1 .6 L/ 1 .73 m2. As
Angina 159 23.4
for Kt/V, this is entirely the result of loss of the renal
Amputation 19 2.8 component, which decreases from 38.8 to 14.3
0 IDDM, insulin-dependent diabetes m ellitus; CHF. congestive heart whereas the peritoneal CCr increases slightly from
failure; Ml, myocardlal infarction. 44.2 to 47.3 L/wk per 1 .73 m2. The serum j32M

200 Volume 7 . Number 2 ‘ 1996

 Churchill et al

Increased from 22.5 to 24.3 mg/L. There is a signifi- TABLE 4. Cox proportional hazards model#{176}
cant increase in SGA, but not for serum albumin
concentration, NPCR, or % LBM. Relative 95%
During the follow-up period of 1 0, 1 38 patient- Variable Mortality Confidence
Risk Interval
months, there were 90 deaths, of which 68 were
classified as cardiovascular, five as infection, four as Age(peryear) 1.03 1.01-1.05
malignancy, and 1 3 as various causes. There were IDDM 1.45 0.89-2.36
137 transplants and 1 18 transfers ( 1 1 1 to hemodial- CVDb 2.09 1.33-3.28
ysis and seven to IPD). Among the remaining 335 Country (USA) 1.93 1.14-3.28
patients, 264 were alive on continuous peritoneal Serum albumin ( I 1 g/L) 0.94 0.90- 0.97
dialysis on December 3 1, 1 993 and were administra- Kt/V ( I 0.1 units/wk) 0.94 0.90-0.99
tiveby censored at that time. Follow-up had been dis- SGA ( f 1 unit) 0.75 0.66-0.85
continued on 7 1 other patients for the following rea-
a Kt/V as estimate of adequacy of dialysis and SGA as the estimate of
sons: noncompliance with dialysate collection (22 nutritional status.
patients); elective withdrawal from dialysis ( 15 pa- b CVD, cardiovascular disease.
tients); move to a non-study dialysis center ( 13 pa-
tients); loss to follow-up ( 13 patients); and recovery of TABLE 5. Cox proportional hazards model#{176}
renal function (8 patients). The Kaplan-Meier esti-
mates of patient survival, technique survival, and the Relative 95%
probability of being alive and on CAPD/CCPD are Variable Mortality Confidence
shown In Figure 1 . The probability of patient survival Risk Interval
to 24 months is 78%; of technique survival, 75%; and
Age(peryear) 1.03 1.01-1.05
of being alive and receiving CAPD treatment, 58%.
IDDM 1 .49 0.92-2.42
CVD 2.12 1.35-3.34
Mortality
Country(USA) 1.95 1.14-3.31
The final Cox proportional hazards model results Serum albumin (f 1 g/1) 0.94 0.90-0.97
are summarized in Tables 4 and 5. In Table 4, Kt/V is CCr ( f 5 L/wk/1 .73 m2) 0.93 0.88- 0.98
used as the estimate of adequacy, whereas CCr is SGA ( I 1 unIt) 0.75 0.66-0.85
used in Table 5. The Schoenfeld residuals were plotted
a OCr as the estimate of adequacy of dialysis and SGA as the
against time for each variable and showed no serious
estimate of nutritional status.
violation of the proportional hazards assumption.
Furthermore, Harrell’s z test detected no violations of
the assumption (37,38). TABLE 6. Expected 2-Year patient survival according
to sustained weekly Kt/V and CCr (1/1.73 m2)
The relative risk (RR) of death for each variable was
slightly different for the two models (Kt/V and CCr). Kt/V Survival % CCr Survival %
Accordingly, where different, both values are pro-
vided. The SGA has been used as the estimate of 2.3 81 95 86
nutritional status rather than NPCR or % LBM be- 2.1 78 80 81
cause it was considered more credible than estimates 1.9 74 70 78
with statistical coupling with adequacy. The PR of 1.7 71 55 72
1.5 66 40 65

death is 1 .03 greater for a 1 -yr difference in age (I.e.,

for two patients identical for all other risk factors.
being 1 yr older increases the PR ofdeath
by 3%). The
0) RR for
those with IDDM was 1 .45 to 1 .49 whereas
C
> those with a history ofCVD had an RR of2.09 to 2.12.
Patients in the United States had a RR ofdeath 1 .93 to
C/) 1 .95 greater than those in Canada. A 1 g/L-lower
C
C.)
serum albumin concentration was associated with an
a. 6% increase in the RR of death. A 1 -U lower SGA score
was associated with a 25% increase In the RR of death.
For two patients who differed only in weekly Kt/V, a
0. 1 lower value was associated with a 6% increase in
the PR of death. For a 5 L/wk per 1 .73 m2 lower CCr,
there was a 7% increase In the RR of death. In
0 6 12 18 24 separate models, 1%-bower % LBM and a 1 mg/L-
Time in Months
greater serum 2M were associated with 3% and 2%
Figure 1 . Probabilities of patient and technique survival. increases in the RR of death, respectively.

Journal of the American Society of Nephrology 201

Adequacy and Nutrition in CAPD

The expected patient survival was estimated for 8

several sustained weekly Kt/V and CCr values. For
weekly Kt/Vvalues of2.3, 2.1, 1.9, 1.7, and 1.5, the
expected 2-yr survivals were 81%, 78%, 74%, 71%,
and 66%. For weekly CCr values of95, 80, 70, 55, and
C
40 L/ 1 732 the expected 2-yr survivals were 86%,
8 1 % 78% 72%
. and 65%
, , . These data are shown in
Table 6 and Figures 2 and 3. CO 8
C

Technique Failure
a.
0
There were 1 18 transfers to hemodialysis or IPD. N.

There were 36 transfers because of peritonitis or

exit-site infection, and five because of catheter mal-
function. There were 19 transfers attributed to mad-
equate dialysis ( 1 2 transfers because of inadequate
0 6 12 18 24
clearance and 7 because of failure of ultrafIltration).
Time in Months
Patient and partner fatigue accounted for two trans-
fers each; social causes were responsible for eight Figure 3. PredIcted probability of patient survival by CCr.
failures. The remaining 46 were considered to be the
results of “other medical” causes. Among the baseline
tional status. CVD, IDDM, and bower serum albumin
demographic and clinical variables, a decreased se-
concentration. Malnutrition, as estimated by the SGA,
rum albumin concentration was associated with an had a strong association with hospitalization. Among
increased risk of technique failure. The RR associated
the estimates of adequacy of dialysis, increased CCr
with a 1 g/L increase was 0.95 (95% CI, 0.92 to 0.98).
and decreased (32M were associated with fewer hospi-
CCr was the only estimate of adequacy which added
tal days, whereas Kt/V was less strongly associated
significantly to this model. The RR associated with a 5
(Table 7).
L/wk per 1 .73 m2 increase was 0.95 (95% CI, 0.9 1 to About 50% of the patients were not hospitalized.
0.99). None of the other estimates of nutrition was
The data were highly skewed and Inappropriate for
associated with technique failure. The PR of technique
usual linear regression methods. Log-linear modeling
failure increased by 5% with a 1 g/L decrease In was used. Among the three estimates of adequacy of
serum albumin concentration and with a 5 L/wk
dialysis. CCr and 2M were significant; Kt/V was not.
decrease in CCr.
Among the three estimates of nutritional status, SGA
and % LBM were significant; NPCR was final not. The
Hospitalization
model, using SGA as the nutrition estimate and CCr
There were 1 239 hospitalizations; the causes were as the adequacy estimate, is shown in Table 8. All
cardiovascular disease ( 189, 15.3%); peritonitis (285, variables were statistically significant (P < 0.05). The
23.0%); gastrointestinal disease ( 120, 9.7%); other exponential coefficient is an expression of the relative
infections (78, 6.3%). No other category accounted for length of time hospitalized compared with the alterna-
more than 5%. There are more days hospitalized tive within the variable. For country, the value 1.23
associated with increased age, female sex, worse func- indicates that patients in centers in the United States
were hospitalized on average 1 .23 times as bong as a
comparable patient in Canada. Each additional year
of age translates into 1 .02 times the time spent in
hospital. Those with Karnofsky scores <80 spent 1.63
times the days hospitalized compared with those with
scores 80. Patients with IDDM and CVD spent 1.47
0)
C and 1 .22 as many days hospitalized as those without
>
IDDM and CVD, respectively. For SGA, a 1 -U increase
Cl) was associated with 0.82 times as many days hospi-
C
talized as those with a score 1 U bower. For serum
8
/32M, a value 1 mg/L greater was associated with 1.02
a.
times as many days hospitalized. A 5 L per week
greater CCr was associated with a 0.99 times as many
days hospitalized.

DISCUSSION
0 6 12 18 24 In a prospective cohort study of patients treated
Time in Months with continuous peritoneal dialysis, the association of
Figure 2. PredIcted probability of patient survival by Kt/V. nutrition and adequacy of dialysis with clinical out-

202 Volume 7 . Number 2 . 1996

 Churchill et al

TABLE 7. Days hospitalized per year TABLE 8. Multiplicative factor on days hospitalized
per month
Factor Days
.
Variable e COEF#{176}
Country
Canada 18.6 Country (USA) 1.23
USA 21.7 Age (1 year) 1.02
Age (yr) Karnofsky (<80) 1.63
<45 10.1 ESRDb
45-64 18.7 (glomerulonephritis) 0.58
>64 29.0 (hypertension-RVD) 0.80
(other) 0.73
Sex
IDDM (present) 1.47
Females 22.7
CVD (present) 1.22
Males 16.7
Serum albumin (1 g/L) 0.95
Karnofsky
SGA (1 unit) 0.82
80 11.3
CCr (5 L/wk per 1.73 m2) 0.99
<80 30.2
CVD a The e0& Is the multiplicative factor Indicating the relative time
Absent 15.2 hospitalized compared to the alternative within the variable (e.g.. for
USA. the alternative is Canada). For continuous variables, the alter-
Present 26.2 natives are 1 year younger for age. 1 gIL less for serum albumin
IDDM concentration, 1 unit less for SGA. and 5 L/wk per 1 .73 m2 less for CCr.
b For ESRD, the alternative is diabetes.
Absent 15.5
Present 31.7
Serum albumin (g/L) 8
>40 7.3
35-40 12.7
0
30-34 23.6
<30 35.6 0)
C
Malnutrition (SGA)
None 13.3 - canada
Mild-moderate 24.8 Cl)
3
----. USA
C
Severe 71.0 G) 0

CCr (L/wk/ 1.73 m2) a.

>80 14.4
0
60-80 17.9
<60 27.8 Number At Risk
Kt/V (wk) Canada 491 343 189
0 USA 81 59 26 10
>2.1 18.1
1.7-2.1 18.7 0 6 12 18 24
<1.7 25.8 Time in Months
f32M (mg/L) Figure 4. Predicted probability of patient survival by country.
>30 26.2
20-30 19.7
80% for those in the Canadian centers compared with
<20 14.6
63% in the U.S. centers. The mean ages were 54.4 and
53.4 yr in Canada and the United States, respectively.
The serum albumin concentration was 34.9 g/L in
comes has been evaluated by using multivariate sta- both countries. Demographic and clinical character-
tistical techniques to control for baseline demographic istics of the patients are compared In Table 9. Statis-
and clinical variables. Better nutrition was associated tically significant differences were present for race,
with better patient survival and fewer days hospital- body surface area, Kt/V (total and peritoneal), and
ized. A higher “dose” of dialysis. inclusive of residual CCr (peritoneaJ). However, all of these variables were
renal function, was associated with better patient controlled in the multivariate analysis. The survival
survival, better technique survival, and fewer days data observed in this study are consistent with data
hospitalized. from Canada (4) and the United States (7). The differ-
The increased RR of death associated with increased ent survival rates are not explained by the variables
age, IDDM, and history of cardiovascular disease was entered in this analysis.
expected. The increased RR of death among patients The degree to which serum albumin concentration
in the centers in the United States (RR 1 .93 to 1.95) is an estimate of nutrition is controversial (39). Fine
was unexpected. The Kapban-Meier patient survival and Cox (40) reported excellent patient survival
curves (Figure 4) show a 2-yr survival probability of among patients with persistently low serum albumin

Journal of the American Society of Nephrology 203

Adequacy and Nutrition in CAPD

TABLE 9. Canada-USA Comparison (47) suggested that the normalized protein catabolic
rate is a flawed marker of nutrition in CAPD patients.
Factor Canada USA They reported negative correlations between PCR nor-
malized by dry weight and other estimates of nutri-
Gender
Male 59% 54% tion. Normalization using standard body weight (V/
Female 41% 46% 0.58) dId not discriminate between well and poorly
nourished patients whereas use of ideal body weight
Race#{176}
from National Health and Nutrition Examination Sur-
Caucasian 85% 66%
African-American 4% 30% vey (NHANES) tables (48) did.
Each of the three estimates of adequacy of dialysis
IDDM 22% 25%
were independently associated with patient survival.
CVD 34% 42%
A 0. 1 difference in weekly Kt/V was associated with a
BSA (m2)#{176} 1.74 1.80 6% difference in the RR of death; a 5-L/week per 1.73
Kt/V (wk) m2 difference in CCr was associated with a 7%
Totala 2.4 2.2 difference.
Peritoneal#{176} 1.7 1.5 When controlling for baseline demographic and
Renal 0.7 0.7 clinical variables, there were associations between
CCr (1 .73 m2/wk) improved patient survival and increased serum albu-
Total 83.8 78.4 mm concentration, greater % LBM, higher SGA
Peritoneala 44.7 41.2 scores, lower serum 2M concentration, greater Kt/V,
Renal 39.1 37.2 and greater CCr.
Several sources of bias were considered. We had
op< 0.05.
censored the 15 withdrawals from dialysis. Analysis
with the withdrawals treated as patient death did not
values. Struijk et al. (4 1 ) found no association be- change the association of estimates of nutrition and
tween serum albumin concentration and patient sur- adequacy of dialysis with patient survival. Events in
vival. The PR for death was 0.89 for a 1 g/L-greater any 6-month period had been attributed to the esti-
serum albumin concentration (95% CI, 0.76 to 1.03) mate of adequacy at the beginning of that period. For
compared with a PR of 0.94 (95% CI, 0.90 to 0.97) in events occurring later in a period, the Kt/V and CCr
this study. The back of statistical significance in the values would have been systematically bower than the
study from the Netherlands may be related to low value at the beginning of that period. A randomized
statistical power (36,42). Teehan et al. (43) found that clinical trial with constant dialysis dose would provide
an average serum albumin concentration less than 35 a more accurate evaluation of the association between
g/L was associated with very poor survival. We found adequacy and clinical outcomes. Estimates of ade-
the serum albumin concentration to be strongly asso- quacy and estimates of nutrition were treated as
dated with mortality. technique failure and hospital- time-dependent covariates. If nutrition were signifi-
ization. A difference of 1 g/L was associated with a 6% cantly affected by adequacy of dialysis, the risk esti-
change in the PR of death, a 5% change in the RR of mate of mortality for adequacy would be incorrect.
technique survival, and a 5% change in days hospi- Analysis with estimates of nutrition entered only as
tabized. baseline variables did not change the risk estimates of
The SGA is a valid clinical estimate of nutrition for mortality for adequacy from those determined by us-
CAPD patients (23). Young and colleagues used SGA ing time-dependent covariates. If there were a rela-
In a study of prevalent CAPD patients and reported tionship between the estimates of adequacy and the
that 8% were severely malnourished, 32% had mild to quality of care provided, the latter could be a con-
moderate malnutrition, and 60% showed no evidence founder, but, in a cohort study, cannot be evaluated.
for malnutrition (44). We found severe and mild to The expected 2-yr survival probabilities (Table 6) are
moderate malnutrition in 4.2% and 5 1 .2% respec- based on the assumption that increases in peritoneal
tiveby of incident CAPD patients. A 1 -U change in this clearance will compensate for the loss of residual
7-point scale is associated with a 25% difference in the renal function and sustain Kt/V and CCr values at a
RR of death. given level. However, the survival probabilities were
Another estimate of nutrition is % LBM, which can generated by deaths that occurred during loss of
be estimated by bioebectrical impedance. near infra- residual renal function without a compensatory in-
red, anthropometrics, or creatinine kinetics (26,45, crease in peritoneal clearance. The assumption that
46). Keshaviah et at. (26) reported an excellent corre- an increase in peritoneal clearance can clinically com-
lation between bioelectrical impedance and near pensate for the loss of residual renal function is
infrared, whereas estimates from creatinine kinetics unproven.
were systematically lower. We found that a 1% differ- Theoretical constructs suggest that the target
ence in % LBM was associated with a 3% change in the weekly Kt/V should be 2.0 to 2.25 (1,2,49,50,51).
RR of death. Several studies have addressed the relationship be-
NPCR was not associated with mortality. Harty et at. tween weekly Kt/V and patient survival by using

204 Volume 7 . Number 2 . 1996

 Churchill et al

univariate analyses (13,15,52,53). Blake et a!. (13) dated with an acceptable level of morbidity and mor-
found no effect of Kt/V on patient survival among 76 tality; optimal dialysis may be defined as the dose
patients. In a study of 102 CAPD patients in Spain beyond which the incremental clinical benefit does not
over 1 2 months, the mean weekly Kt/V value for the justify the added cost or patient burden. Within the
92 patients who survived was 2.0, compared with 1.7 dialysis dose range in this study, higher Kt/V and
for those who died ( 15). Teehan et al. reported a 5-yr higher CCr values were associated with better clinical
survival of >90% for those with a weekly Kt/V >1.89, outcomes. The predicted 2-yr survival of 78% was
compared with <50% for those with less than 1.89 associated with a weekly Kt/V value of 2. 1 . This value
(52). Lamelre et al. (53) reported the changes in Kt/V is within the 2.0 to 2.25 suggested by theoretical
for 16 patients who had survived for 5 yr on CAPD. constructs ( 1 ,2,45,47) and
higher sligl’itly
than the 1.9
There was progressive loss of renal function over 5 yr. to 2.0 suggested by clinical studies ( 15,48,49). A 2-yr
The peritoneal contribution remained > 1 .9 per wk. survival of 78% is better than that currently observed
These clinical studies suggest a target weekly Kt/V In North America (5,59). Pending further studies to
value of 1 .9 to 2. 1 . Unlike Kt/V, there are no theoret- define optimal dialysis. it would appear reasonable to
ical constructs on which to base adequate dialysis provide as high a dialysis dose as is feasible with a
according to CCr. The recommendation of a total CCr Kt/V of 2. 1 or a CCr of 70 L/week per 1 .73 m2
40 to 50 L per 1 .73 m2 per week is based on clinical considered a reasonable target.
experience (54). Strategies to optimize dialysis dose include pre-
Chen et al. have shown an increase in serum 2M scription of exchange volumes based on body surface
with longer duration of CAPD treatment (56). We area (60) and the addition of a nocturnal exchange
found that the serum 32M increased from 22.5 to 24.3 with simple automated devices. The optimal fill vob-
mg/L over 24 months. Chen et a!. (56) also reported a ume for a patient with a body surface area of 1 . 73 m2
weekly peritoneal dialytic 32M removal of 1 19 mg; is 2.5 L. This increases to 3.0 to 3.5 for body surface
Lysaght et at. reported 22 1 mg removed per wk (57). area >2.0 m2 (60). For CCPD patients, one can in-
Given a daily production of 1000 to 1500 mg per wk crease clearance by adding daytime exchanges. If
(58), a decrease in residual renal function should be increased volumes and frequency of exchanges used
associated with an increase in serum 2M. to compensate for declining renal function are unac-
The only independent variables associated with ceptable to the patient, or if therapy cost is excessive,
technique failure were serum albumin concentration transfer to hemodialysis should be considered. Ac-
and CCr. The former could reflect malnutrition, over- cording to the peak urea concentration hypothesis. a
hydration, or both, whereas the latter is an estimate of weekly continuous peritoneal dialysis Kt/V of 2. 1 is
dose of dialysis. Among the factors associated with equivalent to a thrice weekly hemodialysis Kt/V of 1.5
more days hospitalized were increased age, worse (5 1). A transfer to hemodialysis on the basis of Inabil-
functional status, IDDM, and CVD. Malnutrition, es- ity to achieve a weekly Kt/V of 2. 1 would require that
timated by the SGA, had a very strong association a hemodialysis Kt/V of 1 .5 be provided.
with an increase in days hospitalized. A similar asso- The determination of optimal peritoneal dialysis
ciation with decreased serum albumin concentration dose will require further study. In order to achieve it in
may be partly a reflection of nutritional status. In- a cost-effective manner that is consistent with a high
creased CCr was associated with fewer days hospital- quality of life, health-care providers and Industry
ized; there was no association with Kt/V. must work together to optimize the dialysis prescrip-
In this study, the expected 2-yr survival associated tion.
with a sustained weekly Kt/V value of 2. 1 was 78%.
This same 2-yr survival was associated with a weekly
CCr of 70 L/wk per 1 .73 m2. Because ofthe significant
APPENDIX
level of residual renal function in the study popula- CANUSA Peritoneal Dialysis Study Group
tion, these Kt/V and CCr doses were achieved simul-
Affiliations
taneously. With progressive boss of residual renal
function, achievement of the Kt/V target may not be D.N. Churchill, D.W. Taylor, K.E. Thorpe. M.L. Bee-
associated with simultaneous achievement of the CCr croft, St. Joseph’s Hospital. McMaster University,
target. Further study is required to determine which Hamilton, Ontario.
estimate of adequacy should be used clinically. P.R. Keshaviah. G. deVeber, L.W. Henderson, Baxter
The study population had a mean age of 54 yr; 30% Healthcare, Round Lake, Illinois.
had diabetes mebbitus as the cause for ESRD. The 2-yr K.K. Jindal, Victoria General Hospital, Halifax, Nova
survival of 78% exceeds the 73% for a cohort of 45 to Scotia.
64-yr-old patients commencing dialysis in Canada S.S.A. Fenton, J.M. Bargman, D.G. Oreopoubos, The
between 1989 and 1993 (5) and a 66% 2-year survival Toronto Hospital, University of Toronto. Ontario.
reported in the United States (64). This difference in G.G. Wu, Credit Valley Hospital, Mississauga. On-
patient survival times between Canada and the United tario.
States is consistent with that observed in this study. S.D. Lavoie, Ottawa Civic Hospital, University of Ot-
Adequate dialysis may be defined as the dose asso- tawa, Ottawa, Ontario.

Journal of the American Society of Nephrology 205

Adequacy and Nutrition in CAPD

A. Fine, St. Boniface Hospital. University of Manitoba, assessment of continuous ambulatory peritoneal dialy-
Winnipeg. Manitoba. sis patients. ASAIO (Am Soc Artif Intern Organs) Trans
1987:33:650-653.
E. Burgess, Foothills Hospital, University of Calgary, 12. Teehan BP, Schleifer CR, Brown JM, Sigler MH, Rai-
Calgary, Alberta. mondo J: Urea kinetic analysis and clinical outcome on
J.C. Brandes, Medical College of Wisconsin. Milwau- CAPD. A five year longitudinal study. Adv Pent Dial
1990;6: 18 1-185.
kee, Wisconsin. 13. Blake PG. Sombolos K, Abraham G, et at.: Lack of
K.D. Nolph, B.F. Prowant, University ofMissouri Med- correlation between urea kinetic indices and clinical
ical Center, Columbia, Missouri. outcomes in CAPD patients. Kidney mt 199 1:39:700-
706.
D. Page, Ottawa General Hospital, University of Ot-
14. Keshaviah PR, Nolph 1W, Prowant B, et at: Defining
tawa, Ottawa, Ontario. adequacy of CAPD with urea kinetics. Adv Pent Dial
F.X. McCusker, B.P. Teehan, Lankenau Hospital, Tho- 1990:6:173-177.
mas Jefferson Medical College, Philadelphia, Penn- 15. DeAlvaro F, Bajo MA. Alvarez-Ude F, et at.: Adequacy of
peritoneal dialysis: Does KT/V have the same predictive
sylvania. value as in HD? A multicenter study. Adv Pent Dial
M.K. Dasgupta. K. Bettcher, University of Alberta 1992:8:93-97.
Hospital. University of Alberta, Edmonton, Alberta. 16. Brandes JC, Piering WF. Beres JA, Blumenthal 55,
Fritsche C: Clinical outcome of continuous peritoneal
R. Caruana, Medical College of Georgia. Augusta, dialysis predicted by urea and creatinine kinetics. J Am
Georgia. Soc Nephrol 1992:2:1430-1435.
1 7. Arkouche W, Debawari E, My H, et at.: Quantification of
ACKNOWLEDGMENTS adequacy of peritoneal dialysis. Pent Dial Int 1993:
l3ISuppl 21:S215-S218.
This study was funded by the Kidney Foundation ofCanada (Premiere 18. Tzamaloukas AR, Murata GH, Sena P: Assessing the
Clinical Research Award) and by Baxter Healthcare in Canada and in adequacy of peritoneal dialysis. Pent Dial mt 1993:
the United States of America. Funding was also provided by the 13[Suppl 21:5236-5239.
Father Sean O’Sullivan Research Centre (St. Joseph’s Hospital. Ham- 19. Churchill DN: Adequacy of peritoneal dialysis. How
ilton, Ontario); the Kidney Foundation of Manitoba (St. Boniface much dialysis do we need? Kidney Int 1994:46[Suppl
Hospital. Winnipeg. Manitoba): the Foothills Hospital Foundation,
48]:S2-S6.
Calgary. Alberta: the Nephrolog,y Research Fund ofVictoria Hospital. 20. Karnofsky DA. Burchenal JH: The clinical evaluation of
Halifax. Nova Scotia; and the Dialysis Research Fund of the Toronto
chemotherapeutic agents in cancer. In: McLeod CM, Ed.
Evaluation of Chemotherapeutic Agents. New York: Co-
General Division of the Toronto Hospital. Toronto. Ontario. We thank
lumbia University Press: 1949.
Ms. Barbara Leavitt. Mr. Walker Woodworth, and Dr. John Moran of
2 1 . Baker JP, Detsky AS, Wesson DE, et al.: Nutritional
Baxter Healthcare for their support in this study. We also thank Dr.
assessment. A comparison of clinical judgement and
Edward Vonesh for statistical consultation and Ms. Deirdre Hobeck
objective measurements. N Engl J Med 1982:306:969-
for her secretarial skills. Finally. we express our appreciation to the 972.
research assistants in each of the clinical centers for their invaluable 22. Detsky AS, McLaughlin JR. Baker JP, et at.: What is
work. subjective global assessment? J Parenter Enteral Nutr
1987; 11:8-13.
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Journal of the American Society of Nephrology 207