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GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS
Sponsor: Nationwide Children's Hospital
Summary
The GRACE-2 study is a prospective, multi-center, double-blind, randomized controlled trial of the drug GM-CSF vs placebo in children with sepsis-induced multiple organ dysfunction syndrome (MODS) who have immunoparalysis with mild to moderate inflammation.
Key Details
Gender
All
Age Range
1 Day - 17 Years
Study Type
INTERVENTIONAL
Enrollment
141
Start Date
2022-06-14
Completion Date
2025-09-10
Last Updated
2026-04-09
Healthy Volunteers
No
Interventions
GM-CSF
same as arm/group description
Placebo
same as arm/group description
Locations (25)
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Benioff Children's Hospital - Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
University of California - Davis
Sacramento, California, United States
Benioff Children's Hospital - Mission Bay
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
CS Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Children's Hospital of Minnesota
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mercy Children's Hospital
Kansas City, Missouri, United States
Duke University
Durham, North Carolina, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Pennsylvania State University
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Texas Children's Hospital
Houston, Texas, United States
Children's Hospital of San Antonio
San Antonio, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States