CRISIS Prevention Study

Protocol Description

This Phase III study explores methods to reduce the risk of infections and sepsis in children undergoing treatment in pediatric intensive care units (PICUs). Researchers believe it is possible that daily doses of the drug metoclopramide as well as nutritional supplements zinc, selenium and glutamine will reduce the likelihood of new infections and sepsis from occurring in critically ill children. Children’s Hospital of Pittsburgh of UPMC is leading this study involving 7 U.S. hospitals and 600 participants.

Eligibility Criteria

Critically ill boys and girls from ages 1 to 17 may take part in this research study if they meet eligibility requirements. Among those requirements, participants must have as a potential source of infection, at least one of the following: a potential source of infection involving either a mechanical ventilation tube for breathing, a urinary catheter, or a central venous catheter.
Boys: 1 to 17 years
Girls: 1 to 17 years

Requirements

While in the PICU, children will be given the nutritional supplements through a feeding tube, and the drug metoclopramide through an intravenous line.
Visits: Occurs during hospitalization
Duration: Up to 28 days, depending on the severity of the participant’s illness

Status: Open for Enrollment

Source(s) of Support

National Institute of Child Health and Human Development

Additional Information

Study Description at National Institutes of Health

Primary Investigator

Joseph A. Carcillo, MD

Contact Information

To get started, please contact:
Joseph A. Carcillo, MD
412-692-6737