Stress Hydrocortisone In Pediatric Septic Shock

Summary

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

• Septic Shock

Interventions

DRUG

Hydrocortisone, sodium succinate

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.

DRUG

Normal saline

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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Canadian Critical Care Trials Group

  collaborator OTHER

• Children's Hospital of Eastern Ontario

  collaborator OTHER

• Jerry Zimmerman

  lead OTHER

Principal Investigators

• Jerry J Zimmerman MD, MD, PhD · Seattle Children's Hospital, University of Washington School of Medicine

• Michael Agus, MD · Boston Children's Hospital, Harvard Medical School

• Mihir R Atreya, MD, MPH · Children's Hospital Medical Center, Cincinnati

• David Wypij, PhD · Boston Children's Hospital, Harvard Medical School

• Kusum Menon, MD, MSc · Children's Hospital of Eastern Ontario

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-11

Primary Completion

2026-09-30

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States
• Brazil
• Canada
• Israel
• Japan
• Malaysia
• Pakistan
• Saudi Arabia
• Singapore
• Vietnam

Study Locations