PCRRT Multi-Center Registry Data Effective April 1, 2002 Multi-Center Pediatric CRRT Registry Stuart L. Goldstein, MD Assistant Professor of Pediatrics

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

Pat

ient

s

0

2

4

6

8

10

12

14

16

18

20

Houston Boston UAB Seattle


Primary Disease

Primary Disease

Pat

ient

s

0

1

2

3

4

5

6

7

8

9

10

Sep

sis

Car

diom

yopa

thy

RV

T

BM

T

ATN

CV

Sho

ck

Tum

or L

ysis

AM

L

Bow

el P

erf

Met

abx

FO

MO

SF

Nep

hrtx

Met

abol

ic

AR

F

HU

S


pCRRT Registry Modality

MODALITY

Pat

ient

s

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

Pat

ient

Num

ber

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

Pat

ient

s

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

Initi

atio

n

2

6

10

14

18

22

26

30

Death Survival

P < 0.0005


Fluid Overload and Outcome


OUTCOME

Per

cent

Flu

id O

verlo

ad a

t CR

RT

Initi

atio

n

-5

0

5

10

15

20

25

30

35

40

Death Survival

P < 0.05


Fluid Overload and Outcome:Renal Failure Only


OUTCOME

Per

cent

Flu

id O

verlo

ad a

t CR

RT

Initi

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

Circ

uit N

umbe

r

0

3

6

9

12

15

18

21

24

27

30

33

36

Scheduled ChangeClotted

OtherAccess Malfunction

Patient Test


Anticoagulation Method and Circuit Life


Anticoagulation

Circ

uit L

ife (H

ours

)

-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

Documents

PCRRT Multi-Center Registry Data Effective April 1, 2002 Multi-Center Pediatric CRRT Registry Stuart L. Goldstein, MD Assistant Professor of Pediatrics