pCRRT Multi-Center Registry Data Effective April 1, 2002
Multi-Center Pediatric CRRT Registry
Stuart L. Goldstein, MDAssistant Professor of Pediatrics
Baylor College of Medicine
pCRRT Multi-Center Registry Data Effective April 1, 2002
Overview
• Registry study phases– Study design
– Study aims
• Current participating centers– Institutional practice protocol variation
• Current data analysis
pCRRT Multi-Center Registry Data Effective April 1, 2002
pCRRT Registry: Phase 1 Design
• Collect prospective data from 5 to 10 pediatric centers treating 15 to 20 patients annually (200-300 patients over 3 years)
• Each center follows own institutional practice– Patient selection
– Initiation and termination
– Anti-coagulation protocols
– Convection versus diffusion versus hemodiafiltration
– Fluid composition
• Cytokine clearance study
pCRRT Multi-Center Registry Data Effective April 1, 2002
pCRRT Registry: Phase 1 Aims
• Assess for potential associations between various practices and pediatric patient outcomes
• Assess for potential associations between varying practices and CRRT machine functioning
• Determine CRRT clearance rates of various SIRS and CARS cytokines in children with sepsis
pCRRT Multi-Center Registry Data Effective April 1, 2002
Current Registry Centers and PI
• Texas Children’s Hospital (January 2001)• Boston Children’s Hospital (March 2001)• Seattle Children’s Hospital (July 2001)• Univ of Alabama Children’s (July 2001)• Univ of Michigan (December 2002)
• Stuart Goldstein, MD• Michael Somers, MD• Jordan Symons, MD• Timothy Bunchman, MD• Patrick Brophy, MD Melissa
Gregory, MD
pCRRT Multi-Center Registry Data Effective April 1, 2002
Pre-CRRT Registry Data
• Demographics– Primary disease, co-morbid illness, age, gender, days in PICU
• CRRT specifics– Treatment or prevention of fluid overload and/or electrolyte
imbalance
– Access size and site
• Renal failure indices– GFR (Schwartz)
– Percent fluid overload (%FO)
– Urine output in previous 24 hours
pCRRT Multi-Center Registry Data Effective April 1, 2002
Registry PICU Data
• PRISM 2 at ICU admission and CRRT initiation• CRRT initiation
– CVP
– MAP
– Pressor number and specific drugs
– Diuretic use
• CRRT course– Maximum pressor number
– MAP change
– Pressors weaned?
pCRRT Multi-Center Registry Data Effective April 1, 2002
pCRRT Registry Circuit Data
• Separate data page for each circuit
• Machine brand
• Extracorporeal volume
• Priming fluid– NS
– albumin
– blood mixed with • FFP, albumin, or bicarbonate
• Dialysis or replacement fluid composition– Normocarb™ (Dialysis Solutions, Inc)
– Baxter hemofiltration fluid™
– Saline, Ringer’s lactate, peritoneal dialysis fluid
pCRRT Multi-Center Registry Data Effective April 1, 2002
pCRRT Registry Circuit Data
• Anticoagulation– Citrate
– Heparin rate• ACT measured per hour
• Mean ACT
• # ACT < 180 seconds
• Clearance prescription– CVVH versus CVVHD versus CVVHDF
– ml/1.73m2/hour
• Nutrition prescription– Kcal/kg/day
– Grams protein/kg/day
pCRRT Multi-Center Registry Data Effective April 1, 2002
pCRRT Registry Patient Data: Outcome
• Survival versus death (discharge from PICU)• Attainment of target dry weight• Reason to discontinue CRRT
– Death
– Regained renal function
– Underlying illness resolved
– Tolerates intermittent hemodialysis
pCRRT Multi-Center Registry Data Effective April 1, 2002
pCRRT Registry Circuit Data: Outcome
• Filter life-span (hours)• Reason for circuit change
– clotting
– access malfunction
– machine malfunction
– unrelated patient indication (e.g., needs CT scan)
– CRRT discontinued
pCRRT Multi-Center Registry Data Effective April 1, 2002
pCRRT Registry: Results (4/1/2002)
• 42 patients entered into study• 36 with complete data• 128 circuits• 4905 cumulative treatment hours
– Mean 41.2 + 28.9 hours
– Range 1 to 118 hours
pCRRT Multi-Center Registry Data Effective April 1, 2002
Baseline Demographics
Age 8.2 + 7.3 years
Weight 33.8 + 28.4 kg
GFR 35.3 + 25.3 ml/min/1.73m2
pCRRT Multi-Center Registry Data Effective April 1, 2002
Registry Center Census
Center
Pa
tien
ts
0
2
4
6
8
10
12
14
16
18
20
Houston Boston UAB Seattle
pCRRT Multi-Center Registry Data Effective April 1, 2002
Primary Disease
Primary Disease
Pa
tien
ts
0
1
2
3
4
5
6
7
8
9
10
Se
psi
s
Ca
rdio
myo
pa
thy
RV
T
BM
T
AT
N
CV
Sh
ock
Tu
mo
r Ly
sis
AM
L
Bo
we
l Pe
rf
Me
tab
x
FO
MO
SF
Ne
ph
rtx
Me
tab
olic
AR
F
HU
S
pCRRT Multi-Center Registry Data Effective April 1, 2002
pCRRT Registry Modality
MODALITY
Pa
tien
ts
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
CVVH CVVHDF CVVHD SCUF
pCRRT Multi-Center Registry Data Effective April 1, 2002
Reason to Start CRRT
Reason to Start CRRT
Pa
tien
t N
um
be
r
35.9% 35.9%
12.8%
7.7% 7.7%
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
FO Only FO and EI EI Only Other Prevention of FO
pCRRT Multi-Center Registry Data Effective April 1, 2002
Outcome
OUTCOME
Pa
tien
ts
38.9%
61.1%
0
2
4
6
8
10
12
14
16
18
20
22
24
Death Survival
pCRRT Multi-Center Registry Data Effective April 1, 2002
Clinical Variables and Outcome
• Survival not associated with– GFR
– Pressor number
– MAP
– PRISM at ICU admission
– Age
– Weight
• Survival associated with– PRISM at CRRT initiation
– % Fluid overload at CRRT initiation
pCRRT Multi-Center Registry Data Effective April 1, 2002
PRISM at CRRT Initiation and Outcome
±Std. Dev.
±Std. Err.
Mean
OUTCOME
PR
ISM
AT
CR
RT
In
itia
tion
2
6
10
14
18
22
26
30
Death Survival
P < 0.0005
pCRRT Multi-Center Registry Data Effective April 1, 2002
Fluid Overload and Outcome
±Std. Dev.
±Std. Err.
Mean
OUTCOME
Pe
rce
nt
Flu
id O
verl
oa
d a
t C
RR
T I
niti
atio
n
-5
0
5
10
15
20
25
30
35
40
Death Survival
P < 0.05
pCRRT Multi-Center Registry Data Effective April 1, 2002
Fluid Overload and Outcome:Renal Failure Only
±Std. Dev.
±Std. Err.
Mean
OUTCOME
Pe
rce
nt
Flu
id O
verl
oa
d a
t C
RR
T I
niti
atio
n
-5
0
5
10
15
20
25
30
35
40
Death Survival
P < 0.05
pCRRT Multi-Center Registry Data Effective April 1, 2002
Fluid Overload, Severity of Illness and Outcome
• Greater degrees of fluid overload associated with death, even when controlled for severity of illness by PRISM score (multiple regression analysis; p<0.03)
pCRRT Multi-Center Registry Data Effective April 1, 2002
Circuit Change Reason
Reason to Change Circuit
Cir
cuit
Nu
mb
er
0
3
6
9
12
15
18
21
24
27
30
33
36
Scheduled ChangeClotted
OtherAccess Malfunction
Patient Test
pCRRT Multi-Center Registry Data Effective April 1, 2002
Anticoagulation Method and Circuit Life
±Std. Dev.
±Std. Err.
Mean
Anticoagulation
Cir
cuit
Life
(H
ou
rs)
-10
10
30
50
70
90
Heparin Citrate
P < 0.003
N=69
N=38
pCRRT Multi-Center Registry Data Effective April 1, 2002
pCRRT Registry Future Phases
• Assess association between nutrition and outcome
• Assess cytokine levels and clearance
• Test new products devices safely and efficiently
• Prospective randomized trials– Dose
– Fluid options
– Selective cytokine removal
– Time to intervention
– Disease-specific protocol and outcome
• Web-based for easy access and query