Multi-Center Pediatric CRRT Registry

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


Overview

• Registry study phases– Study design

– Study aims

• Current participating centers– Institutional practice protocol variation

• Current data analysis


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 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


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


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


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 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 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 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 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 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


Baseline Demographics

Age 8.2 + 7.3 years

Weight 33.8 + 28.4 kg

GFR 35.3 + 25.3 ml/min/1.73m2


Registry Center Census

Center

Pa

tien

ts

0

2

4

6

8

10

12

14

16

18

20

Houston Boston UAB Seattle


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 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


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


Outcome

OUTCOME

Pa

tien

ts

38.9%

61.1%

0

2

4

6

8

10

12

14

16

18

20

22

24

Death Survival


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


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


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


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


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)


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


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 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

Multi-Center Pediatric CRRT Registry

Documents

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