Professional Documents
Culture Documents
Peritoneal
CANADA-USA
Peritoneal
Principal
Investigators:
David
Taylor, Prakash
R. Keshaviah
Coordinating
Mary Louise
Clinical
Center
Beecroft
Center
Dialysis
N. Churchill,
Investigators:
Investigators:
D. Wayne
Kevin
Kailash
Study
E. Thorpe,
K. Jindal.
Stanley
S.A.
Fenton,
Joanne
M. Bargman,
Dimitrios
G.
Oreopoulos.
David
N. Churchill,
George
G. Wu, Susan
D. Lavoie,
Adrian
Fine,
Ellen
Burgess.
James
C.
Brandes,
Karl D. Nolph,
Barbara
F. Prowant.
Denis
Page,
Francis X. McCusker,
Brendan
P. Teehan,
Mrinal
K. Dasgupta,
Kelvin Bettcher,
Ralph Caruana
Baxter
Lee
Healthcare
Investigators:
George
Soc.
Nephrol.
1996;
7:198-207)
ABSTRACT
The objective
of the study presented
here was to
evaluate
the relationship
of adequacy
of dialysis and
nutritional
status to mortality,
technique
failure,
and
morbidity.
This
was
prospective
cohort
study
680 patients
were
enrolled.
Follow-up
was
termi-
nated December
31 1993. There were 90 deaths,
137
transplants,
and 1 18 technique
failures.
Fifteen withdrew from dialysis. Analysis of the patient and technique
survival
used the Cox proportional
hazards
model with adequacy
of dialysis and nutritional
status
as time-dependent
covariates.
The relative risk (PR) of
death
increased
with increased
age, insulin-dependent diabetes
mellitus,
cardiovascular
disease,
decreased
serum albumin
concentration
and worsened
nutritional
status (subjective
global
assessment
and
percentage
lean body mass). A decrease
of 0. 1 unit
Kt/V per week was associated
with a 5% increase
in
the RR of death; a decrease
of 5 L/1 .73 m2 creatinine
clearance
(CCr) per week was associated
with a 7%
Increase
In the RR of death. The RR oftechnique
failure
,
Received
May
Appendix
November
invesligators
21, 1995.
and
affiliated
104&6673/0702.0198$03.00/0
Journal of the American
Society of Nephrology
copyright
1996 by the American
Society
of Nephrology
198
Clinical
trial,
urea,
creatinine,
multivariate,
pa-
ontinuous
ambulatory
peritoneal
dialysis
1 ,2) is the treatment
used
for approximately
1 4% of the worlds
dialysis
population
(3). With
adjustment
for comorbidity,
Burton
and Walls
(4) and
the Canadian
Organ
Replacement
Register
(5) reported
no difference
between
CAPD and hemodialysis
with
respect
to patient
survival.
However,
Maiorca
et
al.
(6)
found
better
and greater
reported
an
patients
For
ysis
treated
patients
times
survival
treated
increased
with
better
with
these
et
53.5
a!.
yr
(7)
diabetic
studies
longer
status
better
patient
survival
(8,9).
small
molecular
weight
sobutes
decreased
morbidity
( 10). For
CAPD,
some
data
suggest
an
improved
survival
and
better
( 1 1 1 2). There
are conflicting
relationship
between
estimates
and clinical
outcomes
( 13-18).
of
aged
hemodialysis.
nutritional
with
itations
patients
CAPD.
treated
and
for
with
CAPD
while
Held
risk of death
for older
are
dial-
associated
Increased
removal
of
is associated
with
patients
treated
with
association
between
nutritional
status
reports
regarding
the
of adequacy
of dialysis
The methodobogic
lim-
include
small
sample
size
with inadequate
statistical
power,
insensitive
clinical
outcomes,
and use of univariate
rather
than
multivanate
statistical
analysis
(19).
In this article,
we report
the results
of a multicenter
prospective
cohort
study
of 680 patients
commencing
continuous
peritoneal
dialysis
in 14 centers
in Canada and the United
States
between
September
1 1990
and December
3 1 1992,
with follow-up
until
December 3 1 1993.
The objectives
of the study
were:
(1 ) to
evaluate
the association
of adequacy
of dialysis
with
mortality.
technique
failure
and hospitalization;
and
(2) to evaluate
the association
of nutritional
status
with
those
same
variables.
.
organizations.
correspondence
to Dr. D. churchill,
McMaster
University, St. Josephs
50 charlton
Avenue
East, Hamilton,
Ontario,
canada
L8N 4A6.
3
Key Words:
tient survival
of
consecutive
patients commencing
continuous
peritoneal dialysis in 14 centers in Canada
and the United
States. Between September
1 1990 and December31,
1992,
was increased
with decreased
albumin
concentration and
decreased
CCr. Hospitalization
was increased
with decreased
serum albumin
concentration,
worsened
nutrition
according
to subjective
global
assessment
and decreased
CCr. A weekly
Kt/V of 2. 1 and a weekly
CCr of 70 L/ 1.73 m2 were
each
associated
with an expected
2-yr survival
of
78%.
(CAPD)
deVeber,
W. Henderson
(J, Am.
Group23
Hospital,
METHODS
The
order
clinical
centers
participating
of number
of patients
entered,
Volume
in the study,
were Victoria
Number
listed
in
General
1996
Churchill
Hospital
(Halifax,
Nova Scotia);
Toronto
Western
and Toronto
General
Divisions
ofThe
Toronto
Hospital
(Toronto,
Ontario);
St. Josephs
Hospital
(Hamilton.
Ontario):
Credit
Valley
Hospital (Mississaugua,
Ontario);
Ottawa
Civic Hospital
(Ottawa.
Ontario);
St. Boniface
Hospital
(Winnipeg.
Manitoba):
Foot-
hills Hospital
(Calgary,
Alberta);
Medical
College
of Wisconsin (Milwaukee,
Wisconsin);
University
of Missouri
Medical
Center
(Columbia,
Missouri);
Ottawa
General
Hospital
(Ottawa, Ontario):
Lankenau
Hospital
(Philadelphia,
Pennsylvania):
University
of Alberta
Hospital
(Edmonton.
Alberta):
Medical
College
of Georgia
(Augusta,
Georgia).
The Coordinating
Center
was the Department
of Clinical
Epidemiology
and Biostatistics,
McMaster
University,
Hamilton,
Ontario.
All patients
commencing
continuous
peritoneal
dialysis
for
the first time between
September
1 , 1990 and December
31,
1992 were eligible for the study. Exclusion
criteria
were: (1)
being
unlikely
to survive
for at least
6 months;
(2) elective
living donor kidney
transplant
within 6 months;
(3) planned
move
from
the study
center
within
6 months;
(4) positive
hepatitis
B or HIV serology;
(5) active
systemic
inflammatory
disease;
or (6) failure
to sign the informed
consent
form. The
dialysis
prescription
was that prescribed
by the individual
patients
physician.
Changes
were made
for clinical
indications
and
without
reference
to the data
recorded
at the
Coordinating
Center.
The
age.
demographic
sex,
score
race,
(20),
data
recorded
functional
underlying
status
renal
at enrollment
according
disease,
to the
included
Karnofsky
insulin-dependent
dia-
betes
mellitus
(IDDM).
and history
of cardiovascular
disease
(CVD). CVD was defined
as a history
of previous
myocardial
infarction,
angina,
amputation
for vascular
disease,
or Class
III through
IV congestive
heart
failure.
Estimates
of nutritional
status
were
obtained
at enrollment
and every 6 months
thereafter.
If there
was an acute
medical
problem.
this estimate
was obtained
1 month
after
resolution
ofthe
problem.
Serum
albumin
concentration
was
determined
by the bromcresol
green
method.
The subjective
global
assessment
(SGA) of nutritional
status
was
determined
by using
a modification
of the method
described
by
Baker
et a!. and Detsky
et al. (2 1 .22). This
technique
is
reliable
and valid for ESRD patients
treated
with CAPD (23).
Four
items
were scored
on a seven-point
Likard-type
scale,
with
lower values
representing
worse
nutritional
status.
These
values
were
weight
loss during
the past
6 months,
anorexia,
subcutaneous
fat, and muscle
mass.
These
four
items
were
given
subjective
weights
to produce
a global
assessment.
Scores
of 1 to 2 represented
severe
malnutrition;
3 to 5, moderate
to mild
malnutrition;
and
6 to 7,
normal
nutrition.
The protein
catabolic
rate (PCR) was determined
according
to Randerson
et at. (24) and normalized
to
standard
body
weight
(total
body
water/0.58).
Total
body
water
(V) was determined
from the formula
of Watson
et at.
(25).
Percentage
of lean
body
mass
1% LBM] was
determined
from creatinine
kinetics
(26).
Adequacy
of dialysis
was estimated
total weekly
Kt/V for urea,
total weekly
by measurement
creatinine
clearance
of
(CCr),
(f32M]. Peritoneal
Kt
and
serum
beta-2-microglobulin
was estimated
from 24-h
dialysate
urea
excretion
serum
urea concentration.
Renal
Kt was estimated
concurrent
24-h urine
urea
excretion.
Peritoneal
clearance
was estimated
from the 24-h dialysate
excretion
and
the serum
creatinine
concentration
completion
creatinine
excretion
was corrected
for glucose
Interference
by using
correction
factor
(27) determined
for each clinical
laboratory.
The renal
contribution
to creatinine
a validated
chemistry
clearance
Journal
of the
collection.
of the American
Dialysate
and the
from the
creatinine
creatinine
at the
Society
of Nephrology
et al
was estimated
as the average
of renal
creatinine
and urea
clearance
(CCr + Curea)/2
(28). The serum
f32M estimations
were performed
by a solid-phase
time-resolved
fluoroimmunoassay
(DELFIA;
Wallace
Canada.
Vaudreuil,
Quebec)
in
two reference
laboratories.
The clinical
outcomes
were
mortality,
technique
failure,
and hospitalization.
Technique
failure
was defined
as transfer to hemodialysis
or to conventional
intermittent
peritoneal
dialysis.
Hospitalizations
for vascular
access
surgery.
renal
allograft
nephrectomy,
elective
pretransplant
assessment,
and renal transplantation
were excluded
from the analysis
of
the effect
of adequacy
of dialysis
on hospitalization.
The
duration
of follow-up
and total number
of days
hospitalized
were used
to calculate
days
hospitalized
per month
of follow-
up.
Statistical
analysis
of patient
mortality
and
technique
failure
used Andersen
and Gills (29) extension
to the Cox
proportional
hazards
model
(30) with estimates
of nutritional
status
and adequacy
of dialysis
as time-dependent
covariates (31,32).
Events
(e.g., death
or technique
failure)
were
attributed
to the level of nutrition
or adequacy
of dialysis
recorded
at the
6-month
evaluation
preceding
the
event.
Transplantation,
recovery
of renal
function,
technique
failure and loss to follow-up
were censored
observations
for the
patient
survival
analysis.
Death,
transplantation.
recovery
of
renal
function,
and loss to follow-up
were censored
observations for the technique
survival
analysis.
All baseline
demographic
and clinical
variables
and baseline
serum
albumin
concentrations
were entered.
Backward
elimination
removed
nonsignificant
variables.
The three
estimates
of adequacy
of
dialysis
(Kt/V.
CCr, and (32M) were each added
separately
to
this
model.
Three
estimates
of nutritional
status
(NPCR.
SGA, and % LBM) were
each
added
separately
to a model
containing
the significant
baseline
demographic
variables,
serum
albumin
concentration,
and one estimate
of adequacy
of dialysis.
The likelihood
ratio
test
(3 1 .33) was
used
to
determine
whether
or not the addition
of a variable
to a model
added
significantly
to that model.
The validity
of the proportional
hazards
assumption
was considered
for all variables
remaining
in the final models
by examining
the Schoenfeld
residuals
(34).
To further
explore
the effect
of Kt/V
and CCr on patient
survival,
the expected
survival
time
was
determined
for
several
theoretical
Kt/V
and
CCr values.
Survival
curves
were
values
values
survival
values
were
constructed
from
the fitted
models
(3 1 ) for weekly
of 2.3, 2.1,
1.9, 1.7, and
1.5, and
of 95, 80, 70, 55, and 40 L/wk
per
curves
assume
no change
in the
over follow-up
time.
Peritoneal
and
considered
equivalent
with
decreases
Kt/V
for weekly
CCr
1 .73 m2. These
Kt/V
and
CCr
renal
clearance
in renal
function
compensated
by Increased
peritoneal
clearance.
A log-linear
model
was used to analyze
the hospitalization
data
(35). The dependent
variable
was the number
of days
hospitalized
per month
of follow-up.
The baseline
explanatory variables
were:
country
(Canada/United
States);
age at
enrollment;
sex: race (Caucasian
/ non-Caucasian);
Karnofsky score
(<80 or 80):
renal
disease:
IDDM;
and CVD. For
explanatory
variables
estimated
at 6-month
intervals
during
the study.
the weighted
average
was used.
These
variables
were
serum
albumin
concentration,
SGA.
NPCR.
% LBM,
Kt/V,
CCr, and serum
f32M.
The sample-size
calculation
was made
on the basis
of the
patient
survival
analysis.
For the multivariate
analysis.
approximately
ten events
(death)
per independent
variable
are
required
to produce
a model
of reasonable
accuracy
(36).
Given
the ten independent
variables
to be evaluated,
the
199
Adequacy
study
and
population
100 deaths
ment target
the
Nutrition
had
in CAPD
to be large
enough
to experience
about
during
the follow-up
period.
The patient
was 700 patients,
with follow-up
extended
requisite
number
of events
was
enrolluntil
TABLE 2. Adequacy
accumulated.
Kt/V (weekly)
Kt/V renal
Kt/V peritoneal
There
were 680 patients
enrolled
in the study.
There
were 97.9%
treated
with CAPD and 2. 1% with continuous
cycling
peritoneal
dialysis
(CCPD).
The mean
and median
daily
prescribed
instilled
volumes
were
7.7 and 8.0 L, respectively.
The mean
age was 54.3 yr.
with
a range
of 18 to 82 yr. The
distribution
of
demographic
and clinical
factors
is shown
In Table
1.
The mean
height
was 1 .66 m, mean
weight
was 67.8
kg, and mean
body
mass
index
was 24.6 kg per m2.
The baseline
values
for adequacy
of dialysis
and nutritional
status
are shown
in Table
2. By SGA assesswere
30 patients
(4.2%)
with
severe
mal364
(5 1 .2%)
with
mild
to
moderate
and
3 1 7 (44.6%)
considered
well flour-
and
clinical
2.38
0.71
1.67
Race
Caucasian
African American
Asian
Aboriginal
Education
<High school
High school
Technical
College/university
Karnofsky
Gender
Male
Female
Renal Disease
Diabetes
Glomerulonephritis
Nephrosclerosis
Renal vascular
Polycystic
kidney
disease
Other
Comorbidity
IDDM
CHF(111 orlV)
Ml
Angina
Amputation
IDDM,
failure;
0
200
insulin-dependent
Ml,
myocardlal
diabetes
infarction.
0.99
1.89
38.8
44.2
34.6
43.6
18.2
38.5
53.2
50.1
Serum 32M
(mg/I)
Serum albumin
(g/L)
NPCR (g/kg)
SGA (1-7)
% IBM
22.5
21.0
16.0
27.0
34.9
35.0
31.0
39.0
Kt/V.
protein
for urea;
catabolic
1.04
5.19
62.6
1.01
5.00
0.87
4.00
1.19
6.00
53.3
60.9
71.0
OCr. creatinine
clearance
rate; NPCR,
rate; SGA, subjective
global
assessment;
normalized
LBM, lean
mass.
factorsa
N
(%)
558
57
38
20
82.1
8.4
5.6
2.9
1.0
315
187
79
99
46.3
27.5
11.6
14.6
399
58.7
268
39.4
13
1.9
394
57.9
286
42.1
202
95
42
29.7
23.5
14.0
6.2
47
6.9
134
19.7
151
22.2
0.28
156
22.9
ble
99
159
19
14.6
23.4
2.8
progressive
160
disease
2.68
98.0
nutritional
mean
estimates
of
status
(Months)
680
N
Kt/V
Peritoneal
Renal
CCr (1.73 m2)
Peritoneal
Renal
12
525
18
321
24
78
166
2.38
2.25
2.10
2.02
1.99a
1.67
0.71
1.67
0.58
1 .68
0.41
1.66
0.39
1.70
0.28#{176}
83.0
44.2
38.8
74.7
44.6
30.1
68.3
65.7
61.6#{176}
46.4
21.9
45.3
20.4
473b
Serum albumin
(g/L)
NPCR (g/Kg/day)
SGA (0-7)
34.9
35.1
35.1
35.1
35.2
% IBM
62.6
1.03
5.96
63.3
0.97
6.00
63.5
0.96
6.00
63.1
14.3#{176}
Nutrition
Score
80-100
50-70
<50
1.96
0.30
1.37
63.8
Follow-Up
Other
2.28
0.64
1.61
Quartile
78.8
TABLE 3. Weekly
Factor
3rd
1st
Quartile
Median
83.0
body
1 Demographic
status
CCr (1/week
per
1.73 m2)
CCr renal
CCr peritoneal
ished.
TABLE
nutritional
Mean
RESULTS
ment,
there
nutrition,
malnutrition,
and
(baseline)a
a
b
1.04
5.19
601b
65.3
The changes
In adequacy
status
are shown
In Table
numbers
is partly
because
dialysis,
staggered
and
transplantation.
entry
of patients
of dialysis
and
3. The decrease
of death,
transfer
over
but
the
nutritional
in patient
to hemo-
also
study
reflects
period.
total weekly
Kt/V,
there
is a progressive
decrease
2.38 to 1 .99. This decrease
is entirely
the result
of the renal
component.
which
decreases
from
whereas
at
Kt/V,
component,
whereas
44.2
to
for
heart
0.99
1 .67
the
to
decrease
this
the
47.3
peritoneal
1 .70.
For
from
component
total
83.0
the
For
from
of loss
0.71 to
remains
weekly
CCr,
sta-
there
to 6 1 .6 L/ 1 .73
is a
m2.
is entirely
the result
of loss of the
which
decreases
from
38.8
to
peritoneal
CCr increases
slightly
L/wk
per
1 .73 m2. The
serum
Volume
Number
As
renal
14.3
from
j32M
1996
Churchill
Increased
from
22.5
cant
increase
concentration,
During
the
to
24.3
mg/L.
There
for
serum
albumin
of
1 0, 1 38
patient-
months,
there
were
90
deaths,
classified
as cardiovascular,
five
malignancy,
and
1 3 as various
137 transplants
and
1 18 transfers
ysis
and
seven
to IPD).
Among
of
patients,
264
dialysis
tiveby
on December
censored
at
continued
sons:
on
were
alive
3 1,
time.
that
7 1 other
patients);
tients);
tients);
renal
had
for
with
the
(8
following
dialysate
patients).
The
CVDb
2.09
1.33-3.28
1.93
0.94
0.94
0.75
1.14-3.28
0.90- 0.97
Furthermore,
the assumption
The relative
slightly
detected
(37,38).
risk (RR)
of death
papaof
for
two
different
the
models
no violations
variable
(Kt/V
albumin
( I 1 g/L)
I 0.1 units/wk)
f 1 unit)
0.90-0.99
0.66-0.85
Kt/V as estimate
nutritional
status.
of adequacy
CVD, cardiovascular
TABLE
5. Cox
of dialysis
and
of
disease.
proportional
hazards
model#{176}
esti-
and
was
95%
Confidence
Risk
Interval
Age(peryear)
1.03
1.01-1.05
IDDM
CVD
Country(USA)
1 .49
2.12
0.92-2.42
1.35-3.34
(f
Serum albumin
CCr ( f 5 L/wk/1
SGA ( I 1 unIt)
as the
OCr
estimate
of
Relative
Mortality
Variable
no serious
assumption.
for each
(
(
(USA)
rea-
dialysis
( 15
center
( 13
and recovery
and
showed
hazards
Interval
1.01-1.05
Kt/V
SGA
The final
Cox proportional
hazards
model
results
are summarized
in Tables
4 and 5. In Table
4, Kt/V is
used
as the estimate
of adequacy,
whereas
CCr is
used
in Table 5. The Schoenfeld
residuals
were plotted
for each
variable
the
proportional
Harrells
z test
95%
Confidence
0.89-2.36
Mortality
time
of
Relative
Mortality
1.45
mates
of patient
survival,
technique
survival,
and the
probability
of being
alive
and
on CAPD/CCPD
are
shown
In Figure
1 . The probability
of patient
survival
to 24 months
is 78%; of technique
survival,
75%; and
of being
alive and receiving
CAPD treatment,
58%.
against
violation
model#{176}
1.03
Serum
(22
Kaplan-Meier
hazards
Age(peryear)
IDDM
Country
dis-
collection
elective
withdrawal
from
move
to a non-study
dialysis
loss to follow-up
( 13 patients);
function
been
proportional
Risk
which
68 were
as infection,
four
as
causes.
There
were
( 1 1 1 to hemodial-
Follow-up
4. Cox
Variable
the remaining
335
on continuous
peritoneal
1 993 and were administra-
patients
noncompliance
TABLE
is a signifi-
in SGA,
but
not
NPCR,
or % LBM.
follow-up
period
et al
.73 m2)
estimate
of nutritional
of adequacy
CCr).
Accordingly,
where
different,
both
values
are provided.
The SGA has
been
used
as the estimate
of
nutritional
status
rather
than
NPCR
or % LBM because
it was considered
more
credible
than
estimates
with
statistical
coupling
with
adequacy.
The PR of
2-Year
weekly
Kt/V
1.14-3.31
0.90-0.97
0.93
0.88- 0.98
0.75
0.66-0.85
of dialysis
and
SGA
patient
and
survival
CCr
(1/1.73
m2)
Survival
81
95
86
78
80
81
1.7
74
71
1.5
66
70
55
40
78
72
65
Survival
2.3
2.1
1.9
is
two
as the
according
CCr
Kt/V
death
for
1.95
0.94
status.
TABLE 6. Expected
to sustained
1 g/1)
1 .03 greater
for
patients
identical
being
a 1 -yr difference
for all other
the PR ofdeath
in
risk
age (I.e.,
factors.
1 yr older increases
by 3%). The
those
with
IDDM
was
1 .45 to 1 .49 whereas
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
1 .95 greater
than
those
in Canada.
A 1 g/L-lower
serum
albumin
concentration
was associated
with an
6% increase
in the RR of death.
A 1 -U lower SGA score
0)
C
>
C/)
C
C.)
a.
12
Time
Figure
Journal
1 . Probabilities
of the
American
of patient
Society
18
24
in Months
and
technique
of Nephrology
survival.
RR
for
was
associated
with
a 25%
increase
In the
RR of death.
201
Adequacy
The
and
Nutrition
expected
in CAPD
patient
survival
was
estimated
for
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
40 L/ 1 732
the expected
8 1 % 78%
72%
and 65%
Table
6 and Figures
2 and
.
2-yr
survivals
. These
data
3.
were
86%,
are shown
in
CO
Technique
There
There
Failure
were
were
a.
1 18
36
exit-site
infection,
function.
There
transfers
to hemodialysis
transfers
because
and
were
five
of
because
or
peritonitis
of catheter
19 transfers
attributed
or
mal-
to mad-
equate
dialysis
( 1 2 transfers
because
of inadequate
clearance
and
7 because
of failure
of ultrafIltration).
Patient
and partner
fatigue
accounted
for two transfers
each;
social
causes
were
responsible
for eight
significantly
L/wk
per
to this model.
1 .73 m2 increase
0.99).
None
of
associated
with
the
other
technique
Figure
failure
increased
by
serum
decrease
albumin
in CCr.
failure.
The RR associated
0.95
(95%
CI, 0.92
to 0.98).
of adequacy
which
added
The RR associated
with
a 5
was
0.95
estimates
failure.
5%
with
concentration
(95%
of
The
PR
1 g/L
and
CI, 0.9 1 to
nutrition
was
of technique
decrease
with
In
L/wk
Hospitalization
There
were
cardiovascular
23.0%);
1 239 hospitalizations;
disease
( 189, 15.3%);
gastrointestinal
disease
the causes
peritonitis
( 120,
9.7%);
12
18
24
Time in Months
failures.
The remaining
46 were considered
to be the
results
of other
medical
causes.
Among
the baseline
demographic
and clinical
variables,
a decreased
serum
albumin
concentration
was associated
with
an
increased
risk of technique
with
a 1 g/L increase
was
CCr was
the only
estimate
0
N.
IPD.
were
(285,
other
infections
(78, 6.3%).
No other
category
accounted
for
more
than
5%. There
are
more
days
hospitalized
associated
with increased
age, female
sex, worse
func-
3. PredIcted
tional
status.
CVD,
concentration.
a strong
the
and
estimates
decreased
tal
days,
of patient
IDDM,
and
Malnutrition,
had
(Table
probability
association
with
of adequacy
(32M were
whereas
bower
as
by CCr.
serum
albumin
estimated
by the
hospitalization.
of dialysis,
associated
Kt/V
survival
was
less
with
SGA,
Among
increased
fewer
strongly
CCr
hospi-
associated
7).
About
50%
of the
The data
were
highly
usual
linear
regression
was
used.
dialysis.
Among
Among
CCr
and
and
the three
% LBM were
tive
within
patients
were
not hospitalized.
skewed
and Inappropriate
for
methods.
Log-linear
modeling
the
2M
three
estimates
were
significant;
estimates
significant;
of adequacy
Kt/V
of nutritional
NPCR was
of
was
not.
status,
not. The
SGA
final
model,
using
SGA as the nutrition
estimate
and
CCr
as the adequacy
estimate,
is shown
in Table
8. All
variables
were statistically
significant
(P < 0.05).
The
exponential
coefficient
is an expression
of the relative
length
of time hospitalized
compared
with the alternaindicates
the
that
variable.
For
patients
country,
in centers
the
in the
value
1.23
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
and 1 .22 as many
days hospitalized
as those
without
0)
C
>
IDDM
was
Cl)
talized
/32M,
8
a.
and
CVD,
associated
respectively.
with
0.82
For
times
SGA,
as
a 1 -U increase
many
as those
with
a score
1 U bower.
a value
1 mg/L
greater
was
associated
times
as many
greater
CCr was
days
hospitalized.
days
hospitalized.
associated
with
days
hospi-
For serum
with
1.02
A 5 L per week
a 0.99 times
as many
DISCUSSION
0
12
18
24
Time in Months
Figure
202
2. PredIcted
probability
of patient
survival
by Kt/V.
In
a prospective
with continuous
nutrition
and
cohort
peritoneal
adequacy
study
of patients
dialysis,
of dialysis
Volume
treated
the association
with clinical
Number
of
out-
1996
Churchill
TABLE 7. Days
hospitalized
per year
TABLE 8. Multiplicative
per month
factor
on days
hospitalized
Days
Factor
.
Variable
Country
Canada
USA
Age (yr)
<45
Country
Age (1 year)
Karnofsky
(<80)
10.1
ESRDb
18.7
(glomerulonephritis)
(hypertension-RVD)
(other)
IDDM (present)
CVD (present)
Serum
albumin
(1 g/L)
SGA (1 unit)
CCr (5 L/wk per 1.73 m2)
29.0
22.7
16.7
Karnofsky
80
<80
11.3
30.2
15.2
Present
26.2
15.5
Absent
Present
Serum
albumin
1.47
1.22
0.95
0.82
0.99
(g/L)
7.3
12.7
23.6
35.6
Malnutrition
(SGA)
None
Mild-moderate
Severe
CCr (L/wk/ 1.73 m2)
0)
C
13.3
----.
Cl)
24.8
71.0
C
G)
17.9
27.8
>2.1
18.1
1.7-2.1
<1.7
25.8
Number
Canada
USA
Time
19.7
80%
63%
14.6
has
been
techniques
evaluated
to control
by
for
using
multivariate
baseline
demographic
53.4
The
both
sta-
istics
tically
and clinical
variables.
Better
nutrition
was associated
with better
patient
survival
and fewer
days
hospitalized. A higher
dose
of dialysis.
inclusive
of residual
function,
was
better
associated
technique
hospitalized.
The increased
age, IDDM,
and
of the
Figure 4. Predicted
At Risk
59
189
26
10
12
18
24
343
81
probability
in Months
of patient
survival
by country.
26.2
>30
20-30
<20
was
unexpected.
curves
(Figure
491
18.7
f32M (mg/L)
The
USA
Kt/V (wk)
centers
canada
a.
14.4
>80
60-80
<60
Journal
0.58
0.80
0.73
31.7
>40
35-40
30-34
<30
in the
1.02
1.63
Absent
IDDM
expected.
(USA)
The e0&
Is the
multiplicative
factor
Indicating
the relative
time
hospitalized
compared
to the alternative
within the variable
(e.g.. for
USA. the alternative
is Canada).
For continuous
variables,
the alternatives
are 1 year younger
for age.
1 gIL less for serum albumin
concentration,
1 unit less for SGA. and 5 L/wk per 1 .73 m2 less for CCr.
b For ESRD, the alternative
is diabetes.
CVD
renal
survival,
1.23
18.6
Sex
Females
Males
tistical
e COEF#{176}
21.7
45-64
>64
comes
et al
with
survival,
better
and
RR of death
associated
history
of cardiovascular
increased
in the
The
4) show
American
RR
United
of death
States
Kapban-Meier
a 2-yr
Society
with
1 .93
patient
survival
of Nephrology
days
data
compared
with
of the patients
significant
are compared
differences
were
In Table
present
9. Statisfor race,
observed
in
this
study
are
consistent
with
data
patients
from Canada
(4) and the United
States
(7). The different survival
rates
are not explained
by the variables
entered
in this analysis.
The degree
to which
serum
albumin
concentration
to
is an
increased
disease
was
among
(RR
centers
mean
ages were 54.4 and
yr in Canada
and the United
States,
respectively.
serum
albumin
concentration
was
34.9
g/L
in
countries.
Demographic
and clinical
character-
body
surface
area,
Kt/V
(total
and
peritoneal),
and
CCr (peritoneaJ).
However,
all of these
variables
were
controlled
in the multivariate
analysis.
The survival
patient
fewer
for those
in the Canadian
in the U.S. centers.
The
1.95)
survival
probability
of
estimate
and
Cox
(40)
among
patients
of nutrition
is controversial
reported
excellent
with persistently
patient
low serum
(39).
Fine
survival
albumin
203
Adequacy
and
Nutrition
in CAPD
TABLE 9. Canada-USA
Comparison
Factor
(47)
Canada
USA
Gender
suggested
that
the
malized
and
by
dry
weight
59%
54%
41%
46%
85%
66%
4%
30%
IDDM
22%
25%
CVD
BSA (m2)#{176}
34%
42%
A 0. 1 difference
1.74
1.80
6%
2.2
Peritoneal#{176}
1.7
Renal
0.7
1.5
0.7
m2 difference
in
difference.
When
controlling
CCr
2.4
clinical
there
Race#{176}
Kt/V (wk)
Totala
83.8
Each
of the three
were
independently
78.4
41.2
44.7
39.1
Renal
37.2
0.05.
op<
values.
Struijk
et al. (4 1 ) found
no association
between
serum
albumin
concentration
and patient
survival.
The PR for death
was 0.89 for a 1 g/L-greater
serum
albumin
concentration
(95%
CI, 0.76
to 1.03)
compared
with
a PR of 0.94
(95%
CI, 0.90
to 0.97)
in
this study.
study
from
statistical
The
the
back of statistical
Netherlands
may
power
albumin
with
the serum
albumin
dated
with
mortality.
ization.
change
significance
in the
be related
to low
Teehan
et al. (43) found
that
concentration
less than
35
very poor survival.
We found
(36,42).
an average
serum
g/L was associated
concentration
technique
A difference
in the PR
to be strongly
assofailure
and hospital-
technique
survival,
and
a 5% change
tabized.
The SGA is a valid
clinical
estimate
with a 6%
in the RR of
in days
hospi-
other
in the
patients.
PCR nor-
estimates
of
of adequacy
with
patient
Kt/V
RR
was
of death;
was
for
variables,
nutri-
of dialysis
survival.
associated
with
a 5-L/week
per
associated
baseline
with
7%
demographic
were
1.73
and
associations
between
improved
patient
survival
and increased
serum
albumm
concentration,
greater
% LBM,
higher
SGA
scores,
lower serum
2M
concentration,
greater
Kt/V,
and greater
CCr.
Several
sources
of bias
were
considered.
We had
censored
the 15 withdrawals
from
dialysis.
Analysis
with the withdrawals
treated
as patient
death
did not
change
the association
of estimates
of nutrition
and
adequacy
of dialysis
with patient
survival.
Events
in
any
mate
6-month
period
had
of adequacy
at the
been
attributed
beginning
of that
to the
period.
estiFor
events
values
occurring
later
in a period,
the Kt/V
and CCr
would
have been
systematically
bower than
the
value
at the beginning
of that
period.
A randomized
clinical
trial with constant
dialysis
dose would
provide
a more accurate
evaluation
of the association
between
adequacy
and
clinical
outcomes.
Estimates
of adequacy
and
estimates
of nutrition
were
treated
as
time-dependent
covariates.
If nutrition
were
significantly
mate
affected
by
adequacy
of mortality
Analysis
for
estimates
associated
in weekly
difference
with
baseline
of nutrition
catabolic
in CAPD
between
tion.
Normalization
using
standard
body
weight
(V/
0.58)
dId not discriminate
between
well and
poorly
nourished
patients
whereas
use of ideal
body weight
from National
Health
and Nutrition
Examination
Survey (NHANES)
tables
(48) did.
Female
African-American
protein
of nutrition
correlations
Male
Caucasian
normalized
rate is a flawed
marker
They reported
negative
for
estimates
variables
mortality
for
of dialysis,
adequacy
the
would
of nutrition
did
not
adequacy
the
those
risk
esti-
incorrect.
entered
change
from
risk
be
only
as
estimates
determined
of
by
us-
patients
(23). Young
and colleagues
used
SGA
In a study
of prevalent
CAPD
patients
and reported
that 8% were severely
malnourished,
32% had mild to
ing
moderate
founder,
but, in a cohort
study,
cannot
be evaluated.
The expected
2-yr survival
probabilities
(Table
6) are
based
on the assumption
that increases
in peritoneal
clearance
will compensate
for the loss
of residual
renal
function
and sustain
Kt/V
and CCr values
at a
given
level.
However,
the survival
probabilities
were
CAPD
for
malnutrition,
malnutrition
moderate
and
(44).
We
malnutrition
Another
estimated
estimate
by
red,
anthropometrics,
46).
Keshaviah
lation
between
of death.
NPCR was
204
and
patients.
with
or
(26)
not
estimates
lower.
associated
associated
no
evidence
and
mild
5 1 .2%
A 1 -U change
a 25% difference
is % LBM,
impedance.
creatinine
reported
bioelectrical
infrared,
whereas
were
systematically
ence
in % LBM was
RR
severe
4.2%
of nutrition
bioebectrical
et at.
showed
found
in
tiveby of incident
CAPD
7-point
scale is associated
RR of death.
be
60%
(26,45,
excellent
impedance
in this
in the
which
can
near
infra-
kinetics
an
to
respec-
corre-
and
near
from
creatinine
kinetics
We found
that a 1% differwith a 3% change
in the
with
mortality.
Harty
et at.
time-dependent
tionship
between
quality
of
care
the
covariates.
estimates
provided,
the
If there
were
a relaof adequacy
and the
latter
could
be
a con-
generated
by deaths
that
occurred
during
loss
of
residual
renal
function
without
a compensatory
increase
in peritoneal
clearance.
The assumption
that
an increase
in peritoneal
clearance
can clinically
compensate
for the
loss
of residual
renal
function
is
unproven.
Theoretical
weekly
Kt/V
Several
tween
studies
weekly
constructs
should
have
Kt/V
suggest
be
2.0
that
to
2.25
addressed
and
patient
the
Volume
the
target
(1,2,49,50,51).
relationship
survival
by
Number
beusing
1996
Churchill
univariate
analyses
(13,15,52,53).
found
no effect
of Kt/V
on patient
patients.
In a study
of 102 CAPD
over
1 2 months,
the mean
weekly
92
patients
for
those
who
who
survival
survived
died
was
( 15).
of >90%
for
2.0,
compared
with
1.7
et al. reported
a 5-yr
a weekly
Kt/V
>1.89,
Teehan
those
Blake
et a!. (13)
survival
among
76
patients
in Spain
Kt/V
value
for the
with
compared
with
<50%
for those
with
less than
1.89
(52). Lamelre
et al. (53) reported
the changes
in Kt/V
for 16 patients
who had survived
for 5 yr on CAPD.
There
was progressive
loss of renal
function
over 5 yr.
The peritoneal
contribution
remained
> 1 .9 per
wk.
These
clinical
studies
suggest
a target
weekly
Kt/V
value
of 1 .9 to 2. 1 . Unlike
Kt/V,
there
are no theoretical constructs
on which
to base
adequate
dialysis
according
to CCr. The recommendation
of a total CCr
40 to 50 L per 1 .73 m2 per week
is based
on clinical
experience
Chen
et
longer
with
(54).
al. have
duration
with
tality;
beyond
optimal
dialysis
may
be defined
as the dose
which
the incremental
clinical
benefit
does not
the added
cost or patient
burden.
Within
the
dose
range
of
is
within
the
constructs
increase
CAPD
32M
in serum
treatment
increased
2M
(56).
from
2.0
We
provide
as
Kt/V
of
considered
high
simple
for a patient
a daily
production
a decrease
in
crease
increased
associated
with an increase
The
only
independent
1500
mg
function
in serum
variables
per
wk
should
be
2M.
associated
technique
failure
were
serum
albumin
concentration
and CCr.
The former
could
reflect
malnutrition,
overhydration,
or both,
whereas
the latter
is an estimate
of
dose
of dialysis.
Among
the
factors
associated
with
more
days
hospitalized
were
increased
age,
worse
functional
status,
IDDM,
and CVD. Malnutrition,
estimated
by the SGA,
had
a very
strong
association
with an increase
in days hospitalized.
A similar
association
with decreased
serum
albumin
concentration
may
be
partly
creased
a reflection
CCr
was
of
associated
nutritional
with
status.
fewer
days
In-
hospital-
ized;
In
with
This
there
was
this
study,
a sustained
same
2-yr
no association
with
Kt/V.
the expected
2-yr
survival
associated
weekly
Kt/V
value
of 2. 1 was
78%.
survival
was
associated
with
a weekly
CCr
of 70 L/wk
per
level
tion,
of residual
these
Kt/V
taneously.
1 .73
m2.
Because
renal
function
and CCr doses
With
progressive
ofthe
boss
of
of 78%
64-yr-old
between
reported
patient
States
the
73%
for
a cohort
of 45
to
patients
commencing
dialysis
in Canada
1989 and 1993 (5) and a 66% 2-year
survival
in the United
States
(64). This difference
in
survival
times
between
Canada
and the United
is consistent
Adequate
Journal
exceeds
of the
dialysis
American
with
that
may
be defined
Society
observed
in
as the
of Nephrology
and
by
theoretical
sliglitly
dose
as
of 70
target.
optimize
is feasible
L/week
dialysis
with
per
dose
1 .73
include
m2
pre-
devices.
with
clearance
volumes
a body
For
The
optimal
surface
to 3.0
CCPD
fill
area
to 3.5 for
patients,
body
one
surface
can
in-
by adding
daytime
exchanges.
and frequency
of exchanges
for
declining
renal
vob-
of 1 . 73 m2
function
If
used
are
unac-
ceptable
to the patient,
or if therapy
cost is excessive,
transfer
to hemodialysis
should
be considered.
According
to the peak
urea
concentration
hypothesis.
a
weekly
continuous
peritoneal
dialysis
Kt/V
of 2. 1 is
equivalent
to a thrice
weekly
hemodialysis
Kt/V of 1.5
(5 1). A transfer
ity to achieve
a hemodialysis
to hemodialysis
on the basis
of Inabila weekly
Kt/V
of 2. 1 would
require
that
Kt/V
of 1 .5 be provided.
The
determination
dose will require
further
a cost-effective
of
manner
optimal
peritoneal
dialysis
study.
In order
to achieve
it in
that
is consistent
with
life, health-care
providers
and
together
to optimize
the dialysis
a high
Industry
prescrip-
CANUSA
Peritoneal
Affiliations
Dialysis
D.N.
Churchill,
D.W.
croft,
St. Josephs
Taylor,
Hospital.
Study
Group
renal
function,
achievement
of the Kt/V
target
may not be
associated
with simultaneous
achievement
of the CCr
target.
Further
study
is required
to determine
which
estimate
of adequacy
should
be used
clinically.
The study
population
had a mean
age of 54 yr; 30%
had diabetes
mebbitus
as the cause
for ESRD.
The 2-yr
survival
Kt/V
APPENDIX
populasimul-
residual
suggested
and
is 2.5 L. This
increases
area
>2.0
m2 (60).
quality
of
must
work
tion.
significant
in the study
were achieved
2.25
automated
to compensate
with
to
a dialysis
to
ume
to
higher
mor-
scription
of exchange
volumes
based
on body
surface
area
(60) and
the addition
of a nocturnal
exchange
with
renal
study,
and
associated
with better
clinical
2-yr
survival
of 78%
was
Kt/V value
of 2. 1 . This value
2. 1 or a CCr
a reasonable
over
24 months.
Chen
et a!. (56) also reported
a
peritoneal
dialytic
32M
removal
of 1 19 mg;
et at. reported
22 1 mg removed
per wk (57).
of 1000
to 24.3
this
of morbidity
higher
than
the 1.9
to 2.0 suggested
by clinical
studies
( 15,48,49).
A 2-yr
survival
of 78% is better
than
that currently
observed
In North
America
(5,59).
Pending
further
studies
to
define
optimal
dialysis.
it would
appear
reasonable
to
mg/L
weekly
Lysaght
residual
22.5
in
( 1 ,2,45,47)
that
Given
serum
an
level
higher
CCr values
were
outcomes.
The predicted
associated
with a weekly
Strategies
shown
acceptable
found
(58),
the
dated
justify
dialysis
an
et al
this
dose
study.
asso-
Hamilton,
P.R.
K.E.
Thorpe.
McMaster
M.L.
BeeUniversity,
Ontario.
Keshaviah.
Healthcare,
K.K. Jindal,
G. deVeber,
Round
Victoria
L.W.
Lake,
General
Henderson,
Illinois.
Hospital,
Baxter
Halifax,
Nova
Scotia.
S.S.A.
Fenton,
Toronto
G.G.
J.M.
Hospital,
Wu,
Bargman,
D.G.
University
Credit
Valley
Oreopoubos,
of Toronto.
Hospital,
The
Ontario.
Mississauga.
On-
University
of Ot-
tario.
S.D.
tawa,
Lavoie,
Ottawa,
Ottawa
Civic
Hospital,
Ontario.
205
Adequacy
and
A. Fine,
St.
Winnipeg.
Nutrition
Boniface
Manitoba.
in CAPD
Hospital.
E.
Burgess,
Foothills
Calgary,
Alberta.
J.C.
Brandes,
Medical
kee, Wisconsin.
K.D.
D.
Nolph,
B.F.
Hospital,
B.P.
of Calgary,
of Wisconsin.
12.
Milwau13.
Prowant,
McCusker,
of Manitoba,
University
College
University
ical Center,
Columbia,
Page,
Ottawa
General
tawa,
Ottawa,
Ontario.
F.X.
University
ofMissouri
Missouri.
Hospital,
Teehan,
University
Lankenau
mas
Jefferson
Medical
College,
sylvania.
M.K.
Dasgupta.
K. Bettcher,
Hospital.
University
of Alberta,
R. Caruana,
Medical
College
Georgia.
Medof Ot-
Hospital,
Tho-
Philadelphia,
1990:6:173-177.
15.
Penn-
University
Edmonton,
of Georgia.
of
Alberta
Alberta.
Augusta,
ACKNOWLEDGMENTS
This
study
Clinical
was
funded
Research
the
United
Father
ilton,
by
States
of
Sean
OSullivan
Ontario);
the
Calgary.
Hospital.
Winnipeg.
Alberta:
Halifax.
Nova
the
Kidney
and
Award)
by
America.
Manitoba):
Nephrolog,y
the
Scotia;
and
the
Healthcare
Edward
for
for
Vonesh
her
research
for
secretarial
assistants
Funding
was
their
skills.
in each
(Premiere
in Canada
also
Research
support
in this
consultation
Finally.
we
of the
express
clinical
Fund
Toronto.
and
study.
and
our
centers
by
in
the
Hospital.
Ham(St.
Boniface
the
Foothills
Hospital
Research
Fund
ofVictoria
Hospital.
Woodworth,
and
provided
(St. Josephs
of Manitoba
Dialysis
statistical
ofCanada
Healthcare
Research
Centre
Kidney
Foundation
General
Division
of the Toronto
Ms. Barbara
Leavitt.
Mr. Walker
Baxter
Foundation
Baxter
Foundation,
Hospital.
of the
Toronto
Ontario.
Dr. John
We thank
Moran
of
We
thank
Ms.
also
Deirdre
appreciation
for their
Dr.
Hobeck
to
the
invaluable
work.
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