RECRUITING

Stress Hydrocortisone In Pediatric Septic Shock

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).

Conditions

Study Overview

Study Details

Study overview

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).

Stress Hydrocortisone In Pediatric Septic Shock

Stress Hydrocortisone In Pediatric Septic Shock

Condition
Septic Shock
Intervention / Treatment

-

Contacts and Locations

Tucson

University of Arizona Medical Centre, Tucson, Arizona, United States, 85724

Los Angeles

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

Oakland

UCSF Benioff Children's Hospital - Oakland, Oakland, California, United States, 94609

Orange

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

San Francisco

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

Wilmington

Nemours Children's Health, Wilmington, Delaware, United States, 19803

Chicago

University of Chicago, Comer Children's Hospital, Chicago, Illinois, United States, 60637

Peoria

The University of Illinois at Chicago/OSF Children's Hospital of Illinois, Peoria, Illinois, United States, 61603

Louisville

University of Louisville, Norton Children's Hospital, Louisville, Kentucky, United States, 40202

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

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

    Ages Eligible for Study

    1 Month to 17 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    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

    2026-12-31