The CRISIS Prevention Study

Summary

Despite strict hand washing, sterile technique, and antibiotic-coated catheters, nosocomial infection and sepsis remain the leading acquired causes of morbidity and mortality in critically ill children. Subsequent use of antibiotics to treat nosocomial infection and sepsis is considered a major attributable factor in the rise of antibiotic-resistant organisms in this population of children. This study will use a double-blind, randomized, controlled trial design to test the hypothesis that daily prophylaxis with metoclopramide, zinc, selenium and glutamine will reduce nosocomial infection and sepsis in critically ill children.

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

Sponsors & Collaborators

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

  collaborator NIH

• Seattle Children's Hospital

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• Arkansas Children's Hospital Research Institute

  collaborator OTHER

• Children's Hospital of Michigan

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Children's National Research Institute

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• Harborview Injury Prevention and Research Center

  collaborator OTHER

• Michael Dean

  lead OTHER

Principal Investigators

• Joseph Carcillo, MD · University of Pittsburgh Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-04-30

Primary Completion

2009-11-30

Completion

2009-11-30

Countries

• United States

Study Locations