RecruitingPhase 2Phase 3NCT05267821
Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS
Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)
Sponsor
Nationwide Children's Hospital
Enrollment
500 participants
Start Date
Jun 14, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
The TRIPS study is a prospective, multi-center, double-blind, adaptively randomized, placebo-controlled clinical trial of the drug anakinra for reversal of moderate to severe hyperinflammation in children with sepsis-induced multiple organ dysfunction syndrome (MODS).
Eligibility
Min Age: 1 DayMax Age: 17 Years
Inclusion Criteria4
- ≥ 40 weeks corrected gestational age to \< 18 years; AND
- Admission to the PICU or CICU; AND
- Onset of ≥ 2 new organ dysfunctions within the last 3 calendar days (compared to pre-sepsis baseline) as measured by the modified Proulx criteria; AND
- Documented or suspected infection as the MODS inciting event.
Exclusion Criteria12
- Weight \<3kg; OR
- Limitation of care order at the time of screening; OR
- Patients at high likelihood of progression to brain death in opinion of the clinical team; OR
- Moribund condition in which the patient is unlikely to survive the next 48 hours in opinion of the clinical team; OR
- Current or prior diagnosis of hemophagocytic lymphohistiocytosis or macrophage activation syndrome; OR
- Peripheral white blood cell count \< 1,000 cells/mm3 as the result of myeloablative therapy OR receipt of myeloablative therapy within the previous 14 days; OR
- Known allergy to anakinra, or E. coli-derived products; OR
- Known pregnancy; OR
- Lactating females; OR
- Receipt of anakinra within the previous 28 days; OR
- Resolution of MODS by MODS Day 2; OR
- Previous enrollment in the TRIPS study.
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Interventions
DRUGAnakinra
See information in arm/group descriptions
DRUGPlacebo
See information in arm/group descriptions
Locations(32)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05267821