RECRUITING

Stress Hydrocortisone In Pediatric Septic Shock

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

SHIPSS is a multi-institutional, prospective, controlled, randomized, double-blinded interventional trial that will examine the potential benefits and risks of adjunctive hydrocortisone prescribed for children with fluid and vasoactive-inotropic refractory septic shock. It is hypothesized that adjunctive hydrocortisone will significantly reduce the incidence of new and progressive organ dysfunction (primary outcome) and proportion of children with poor outcomes, defined as death or severely impaired health-related quality of life (HRQL) (secondary outcome), as assessed at 28 days following study enrollment (randomization).

Official Title

Stress Hydrocortisone In Pediatric Septic Shock

Quick Facts

Study Start:2019-03-11
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03401398

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 Month to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Jerry J Zimmerman, MD, PhD
CONTACT
206-987-3862
jerry.zimmerman@seattlechildrens.org
Kusum Menon, MD, MSc
CONTACT
613-737-7600
menon@cheo.on.ca

Principal Investigator

Jerry J Zimmerman MD, MD, PhD
PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital, University of Washington School of Medicine
Michael Agus, MD
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital, Harvard Medical School
Hector R Wong, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
David Wypij, PhD
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital, Harvard Medical School
Kusum Menon, MD, MSc
PRINCIPAL_INVESTIGATOR
Children's Hospital of Eastern Ontario

Study Locations (Sites)

University of Arizona Medical Centre
Tucson, Arizona, 85724
United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027
United States
UCSF Benioff Children's Hospital - Oakland
Oakland, California, 94609
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
UCSF Benioff Children's Hospital - San Francisco
San Francisco, California, 94143
United States
Nemours Children's Health
Wilmington, Delaware, 19803
United States
University of Chicago, Comer Children's Hospital
Chicago, Illinois, 60637
United States
The University of Illinois at Chicago/OSF Children's Hospital of Illinois
Peoria, Illinois, 61603
United States
University of Louisville, Norton Children's Hospital
Louisville, Kentucky, 40202
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
The Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
United States
Penn State Milton S. Hershey Children's Hospital
Hershey, Pennsylvania, 17033
United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38163
United States
Primary Children's Hospital
Salt Lake City, Utah, 84108
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States
University of Wisconsin Health/American Family Children's Hospital
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Jerry Zimmerman

  • Jerry J Zimmerman MD, MD, PhD, PRINCIPAL_INVESTIGATOR, Seattle Children's Hospital, University of Washington School of Medicine
  • Michael Agus, MD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital, Harvard Medical School
  • Hector R Wong, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati
  • David Wypij, PhD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital, Harvard Medical School
  • Kusum Menon, MD, MSc, PRINCIPAL_INVESTIGATOR, Children's Hospital of Eastern Ontario

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 Date2019-03-11
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2019-03-11
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • hydrocortisone
  • refractory septic shock
  • sepsis
  • new/progressive MODS
  • mortality
  • health-related quality of life
  • corticosteroid adverse events
  • sepsis biomarkers

Additional Relevant MeSH Terms

  • Septic Shock