Nationwide Children's Hospital
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).
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). Eligible subjects will undergo centralized immunophenotyping on day 2 of MODS. Subjects without immunoparalysis (a whole blood ex vivo LPS-induced TNF-alpha production capacity \< 200 pg/ml) and a serum ferritin level of 500 - 2,000 ng/ml or a serum C-reactive protein (CRP) ≥ 4 mg/dl will be eligible for randomization, along with…
Inclusion Criteria: * ≥ 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 Criteria: * 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…
See information in arm/group descriptions
See information in arm/group descriptions