The CRISIS Prevention Study
Public ClinicalTrials.gov record NCT00395161. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Critical Illness Stress-induced Immune Suppression Prevention Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00395161
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 293 participants
Conditions and interventions
Conditions
Interventions
- Metoclopramide Drug
- Zinc Drug
- Glutamine Dietary Supplement
- Selenium Drug
- saline Other
- sterile water Other
- selenium Other
- whey-protein Dietary Supplement
Drug · Dietary Supplement · Other
Eligibility (public fields only)
- Age range
- 12 Months to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2007 (Type not available)
- Primary completion
- Nov 2009 (Actual)
- Completion
- Nov 2009 (Actual)
- Last update posted
- Apr 18, 2013
2007 – 2009
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| Childrens Hospital of Los Angeles | Los Angeles | California | 90027 | — |
| University of California Los Angeles Medical Center | Los Angeles | California | 90095 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00395161, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 18, 2013 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00395161 live on ClinicalTrials.gov.