Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anakinra, Placebo.
- Who it may be relevant to
- Registry conditions: Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS). Basic parameters: 1 Day — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)
Overview
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).
Detailed description
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 subjects with a serum ferritin level of 2,000 - 10,000 ng/ml regardless of their TNF-alpha response. Eligible subjects will receive intravenous (IV) anakinra at a dose of 4, 8, 12, or 16 mg/kg/day or placebo for 7 days.
Interventions
- Drug Anakinra
See information in arm/group descriptions - Drug Placebo
See information in arm/group descriptions
Primary outcome measures
- Cumulative 28-day Pediatric Logistic Organ Dysfunction (PELOD-2) score [Time frame: 28 days from randomization]
Secondary outcome measures (2)
- 3-month health-related quality of life [Time frame: 3 months post-randomization]
- 3-month functional status [Time frame: 3 months post-randomization]
Eligibility criteria
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 32 centers
- Children's of Alabama — Birmingham
- Arkansas Children's Hospital — Little Rock
- Children's Hospital of Los Angeles — Los Angeles
- Benioff Children's Hospital - Oakland — Oakland
- Children's Hospital of Orange County — Orange
- University of California, Davis — Sacramento
- Rady Children's Hospital — San Diego
- Benioff Children's Hospital - Mission Bay — San Francisco
- … and 24 more centers
Publications
- VanBuren JM, Hall M, Zuppa AF, Mourani PM, Carcillo J, Dean JM, Watt K, Holubkov R. The Design of Nested Adaptive Clinical Trials of Multiple Organ Dysfunction Syndrome Children in a Single Study. Pediatr Crit Care Med. 2023 Dec 1;24(12):e635-e646. doi: 10.1097/PCC.0000000000003332. Epub 2023 Jul 27. PMID 37498156
Identifiers
NCT: NCT05267821 · TRIPS