The CRISIS Prevention Study

PHASE3TerminatedINTERVENTIONAL
Enrollment

293

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Sepsis
Interventions
DRUG

Metoclopramide

0.2 mg/kg/dose IV every 12 hours

DRUG

Zinc

one enteral dose daily of zinc chloride (10 mg/day elemental zinc for infants \< or equal to one year of age, and 20 mg/day elemental zinc for patients \> 1 year of age)

DIETARY_SUPPLEMENT

Glutamine

one enteral dose daily of glutamine 0.3 gm/kg/day

DRUG

Selenium

one enteral dose daily of selenium (40 μg for infants \< 8 months of age, 60 μg for infants 8 to 12 months of age, 90 μg for children 1-3 years, 150 μg for children 4-8 years, 280 μg for children 9 to 13 years, and 400 μg for children \> 13 years)

OTHER

saline

equivalent volume of intravenous saline

OTHER

sterile water

equivalent volume of sterile water

OTHER

selenium

equivalent volume of sterile water

DIETARY_SUPPLEMENT

whey-protein

one enteral dose daily of whey-protein

Trial Locations (7)

15213

University of Pittsburgh Medical Center, Pittsburgh

20010

Children's National Medical Center, Washington D.C.

48201

Children's Hospital of Michigan, Detroit

72202

Arkansas Children's Hospital, Little Rock

90027

Childrens Hospital of Los Angeles, Los Angeles

90095

University of California Los Angeles Medical Center, Los Angeles

98105

Seattle Children's Hospital, Seattle

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

Seattle Children's Hospital

OTHER

collaborator

Children's Hospital Los Angeles

OTHER

collaborator

Arkansas Children's Hospital Research Institute

OTHER

collaborator

Children's Hospital of Michigan

OTHER

collaborator

University of Pittsburgh

OTHER

collaborator

Children's National Research Institute

OTHER

collaborator

University of California, Los Angeles

OTHER

collaborator

Harborview Injury Prevention and Research Center

OTHER

lead

Michael Dean

OTHER