Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

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).

Conditions

Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)

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Study Overview

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Study Details

Study 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).

Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)

Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

Condition
Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)
Intervention / Treatment

-

Contacts and Locations

Little Rock

Arkansas Children's Hospital, Little Rock, Arkansas, United States, 72202

Los Angeles

Children's Hospital of Los Angeles, Los Angeles, California, United States, 90027

Oakland

Benioff Children's Hospital - Oakland, Oakland, California, United States, 64609

Orange

Children's Hospital of Orange County, Orange, California, United States, 92868

San Francisco

Benioff Children's Hospital - Mission Bay, San Francisco, California, United States, 94143

Aurora

Children's Hospital Colorado, Aurora, Colorado, United States, 80045

Washington

Children's National Medical Center, Washington, District of Columbia, United States, 20010

Ann Arbor

CS Mott Children's Hospital, Ann Arbor, Michigan, United States, 48109

Detroit

Children's Hospital of Michigan, Detroit, Michigan, United States, 48201

Minneapolis

Children's Hospital of Minnesota, Minneapolis, Minnesota, United States, 55404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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
  • * History of myeloid leukemia, myelodysplasia, or autoimmune thrombocytopenia; 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 therapyOR 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 or GM-CSF within the previous 28 days; OR
  • * Resolution of MODS by MODS Day 2; OR
  • * Previous enrollment in the TRIPS study.

Ages Eligible for Study

1 Day to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Nationwide Children's Hospital,

Study Record Dates

2027-08-31