THE CRITICAL ILLNESS STRESS-INDUCED IMMUNE SUPPRESSION

$489M01FY2010RRNIH

Children'S Research Institute, Washington DC

Investigators

Linked publications & trials

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Abstract

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Critical Illness Stress-Induced Immune Suppression Prevention Trial has maintained ongoing enrollment. Both the DCC (Data Coordinating Center, Salt Lake City, Utah) and the Principal Investigator, Joseph Carcillo, MD, Pittsburgh Children's Hospital have been pleased with enrollment. Pittsburgh has the highest enrollment of 30 children/families. This was anticipated due to the size/acuity of the Pediatric Intensive Care Unit (one of largest PICU's in US). There have been minor modifications with the trial. None of these have required a change in consent. A modification was posted 2/8/08 addressing the stability of one of the oral supplements, glutamine. The protocol was amended from a 30 minute stability time to 6 hours. The DSMB will meet after 200 children are enrolled. To date, there have not been any adverse events associated with the administration of metoclopramide/nutritional supplements. There has not been interim data analysis/outcome of this protocol.

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