Status:
ACTIVE_NOT_RECRUITING
GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study
Lead Sponsor:
Nationwide Children's Hospital
Conditions:
Pediatric Sepsis-induced MODS
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE4
Brief Summary
This study is an open-label, multi-center, interventional trial in which children with sepsis-induced MODS undergo surveillance immune function testing beginning on Day 2 of MODS. Those children who d...
Eligibility Criteria
Inclusion
- \>= 40 weeks gestational age to \<18 years; AND
- Onset of \>=2 new organ dysfunctions (compared to pre-sepsis baseline) as measured by the Proulx criteria; AND
- Documented or suspected infection as the MODS inciting event.
Exclusion
- Unable to collect a cumulative total of 20.5 mL of blood for this study due to research blood draw limits; OR
- Limitation of care order at the time of screening; OR
- Patients at high risk for brain death; OR
- Active (or planned within 7 days) immunosuppressive treatment for oncologic, transplant, or rheumatologic disease; OR
- Known primary immunodeficiency disorder; OR
- Diagnosis of myeloid leukemia, myelodysplasia, or autoimmune thrombocytopenia;OR
- Known allergy to GM-CSF; OR
- Documented hyperferritinemia (serum ferritin \>= 500 ng/ml) during current sepsis event; OR
- Contraindication to SQ injection (ECMO); OR
- Burns where \>5% of the total body surface area is affected; OR
- Renal replacement therapy at the time of screening; OR
- On ECMO or anticipated to require ECMO; OR
- Known pregnancy; OR
- Inability to collect and ship sample for immune testing on MODS Day 2; OR
- Previous enrollment in the GRACE study
Key Trial Info
Start Date :
December 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 5 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03769844
Start Date
December 5 2018
End Date
December 5 2023
Last Update
February 8 2023
Active Locations (8)
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1
UCLA Mattel Children's Hospital
Los Angeles, California, United States, 90095
2
Benioff Children's Hospital/UCSF
San Francisco, California, United States, 94158
3
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
4
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010