RECRUITING

Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

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Conditions

Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2022-06-14
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05267821

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.

Ages Eligible for Study:1 Day to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * ≥ 40 weeks corrected gestational age to \< 18 years; AND
  2. * Admission to the PICU or CICU; AND
  3. * 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
  4. * Documented or suspected infection as the MODS inciting event.
  1. * Weight \<3kg; OR
  2. * Limitation of care order at the time of screening; OR
  3. * Patients at high likelihood of progression to brain death in opinion of the clinical team; OR
  4. * Moribund condition in which the patient is unlikely to survive the next 48 hours in opinion of the clinical team; OR
  5. * History of myeloid leukemia, myelodysplasia, or autoimmune thrombocytopenia; OR
  6. * Current or prior diagnosis of hemophagocytic lymphohistiocytosis or macrophage activation syndrome; OR
  7. * 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
  8. * Known allergy to anakinra, or E. coli-derived products; OR
  9. * Known pregnancy; OR
  10. * Lactating females; OR
  11. * Receipt of anakinra or GM-CSF within the previous 28 days; OR
  12. * Resolution of MODS by MODS Day 2; OR
  13. * Previous enrollment in the TRIPS study.

Contacts and Locations

Study Contact

Mark Hall, MD
CONTACT
6147223438
mark.hall@nationwidechildrens.org

Study Locations (Sites)

Arkansas Children's Hospital
Little Rock, Arkansas, 72202
United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027
United States
Benioff Children's Hospital - Oakland
Oakland, California, 64609
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Benioff Children's Hospital - Mission Bay
San Francisco, California, 94143
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
CS Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Children's Hospital of Minnesota
Minneapolis, Minnesota, 55404
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Mercy Children's Hospital
Kansas City, Missouri, 64108
United States
Duke University
Durham, North Carolina, 27705
United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Pennsylvania State University
Hershey, Pennsylvania, 17033
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15260
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
Children's Hospital of San Antonio
San Antonio, Texas, 78207
United States
Primary Children's Hospital
Salt Lake City, Utah, 84158
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53233
United States

Collaborators and Investigators

Sponsor: Nationwide Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-14
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2022-06-14
Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)