Stress Hydrocortisone In Pediatric Septic Shock

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Jerry Zimmerman
Study ID
NCT03401398
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Septic Shock

Eligibility Criteria

Sex
ALL
Age
1 Month - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Hydrocortisone, sodium succinate — DRUG
    Patients randomized to the hydrocortisone treatment arm will receive an initial bolus of 2 mg/kg IV hydrocortisone, followed by 1 mg/kg (maximum 50 mg) of hydrocortisone dosed every six hours for a maximum of seven days or until all vasoactive infusions have been discontinued for at least 12 hours, whichever comes first. When the hydrocortisone course is completed, the medication will be discontinued.
  • Normal saline — DRUG
    Patients randomized to the placebo treatment arm will receive an equivalent volume of normal saline, with the identical dosing schedule to the intervention (hydrocortisone) arm.

Study Details

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).

Key Dates

Start date
Mar 11, 2019
Status verified
May 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment
    Approximately half of the subjects randomized into SHIPSS will be randomized into the Treatment Group and will receive hydrocortisone sodium succinate according to a predetermined dosing schedule.
  • Placebo Comparator: Placebo
    Approximately half of the subjects randomized into SHIPSS will be randomized into the Placebo Group and will receive equivalent study drug volumes of normal saline.

Primary Outcome Measure

New or progressive multiple organ dysfunction syndrome as assessed utilizing the Pediatric Logistic Organ Dysfunction (PELOD-2) instrument. [ Time Frame: 28 days following study enrollment ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
University of Arizona Medical CentreTucsonArizona85724
Katri Typpo, MD
Children's Hospital of Los AngelesLos AngelesCalifornia90027
Christopher Newth, MD
UCSF Benioff Children's Hospital - OaklandOaklandCalifornia94609
Natalie Cvijanovich, MD
Children's Hospital of Orange CountyOrangeCalifornia92868
Adam Schwarz, MD
UCSF Benioff Children's Hospital - San FranciscoSan FranciscoCalifornia94143
Patrick McQuillen, MD
[email protected]
Matt Zinter, MD
[email protected]
Nemours Children's HealthWilmingtonDelaware19803
Catherine Madurski, MD
University of Chicago, Comer Children's HospitalChicagoIllinois60637
Grace Chong, MD
The University of Illinois at Chicago/OSF Children's Hospital of IllinoisPeoriaIllinois61603
Sandeep Tripath, MD
University of Louisville, Norton Children's HospitalLouisvilleKentucky40202
John Berkenbosch, MD
Boston Children's HospitalBostonMassachusetts02115
Michael Agus, MD
Saint Barnabas Medical CenterLivingstonNew Jersey07039
Shira J Gertz, MD
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Ranjit R Chima, MD
The Children's Hospital at Oklahoma University Medical CenterOklahoma CityOklahoma73104
Christine Allen, MD
Penn State Milton S. Hershey Children's HospitalHersheyPennsylvania17033
Robert Kavanagh, MD
Le Bonheur Children's HospitalMemphisTennessee38163
Samir Shah, MD
Primary Children's HospitalSalt Lake CityUtah84108
Jennifer Workman, MD
Seattle Children's HospitalSeattleWashington98105
Jerry J Zimmerman, MD, PhD
University of Wisconsin Health/American Family Children's HospitalMadisonWisconsin53792
Pelin Cengiz, MD

Find similar trials in Tucson, AZ

By research site
University of Arizona Medical Centre· Tucson, AZChildren's Hospital of Los Angeles· Los Angeles, CAUCSF Benioff Children's Hospital - Oakland· Oakland, CAChildren's Hospital of Orange County· Orange, CAUCSF Benioff Children's Hospital - San Francisco· San Francisco, CANemours Children's Health· Wilmington, DE

Related Studies