NCT03401398: SHIPSS

Stress Hydrocortisone In Pediatric Septic Shock

Recruiting now Phase 3 Last updated 30 October 2025

What this trial tests

Phase 3 trial testing Hydrocortisone, sodium succinate in Septic Shock in 500 participants. Currently enrolling.

Timeline

11 March 2019

Primary endpoint
30 September 2026

31 December 2026

Quick facts

Lead sponsor	Jerry Zimmerman
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	500
Start date	11 March 2019
Primary completion	30 September 2026
Estimated completion	31 December 2026
Sites	44 locations across Pakistan, Japan, Malaysia, Saudi Arabia, Israel, Vietnam, Canada, Singapore

Drugs / interventions tested

• Hydrocortisone, sodium succinate
• Normal saline

Conditions studied

• Septic Shock — all drugs for Septic Shock →

Sponsor

Jerry Zimmerman

Who can join

Adults 1 Month to 17, any sex, with Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prospective clinical testing and experimental validation of the Pediatric Sepsis Biomarker Risk Model.
   Wong HR, Caldwell JT, Cvijanovich NZ, Weiss SL, et al · · 2019 · cited 60× · PMID 31723040 · DOI 10.1126/scitranslmed.aax9000
2. Pediatric Sepsis Diagnosis, Management, and Sub-phenotypes.
   Weiss SL, Fitzgerald JC. · · 2024 · cited 39× · PMID 38084084 · DOI 10.1542/peds.2023-062967
3. External Corroboration That Corticosteroids May Be Harmful to Septic Shock Endotype A Patients.
   Wong HR, Hart KW, Lindsell CJ, Sweeney TE. · · 2021 · cited 39× · PMID 33156120 · DOI 10.1097/ccm.0000000000004709
4. Corticosteroids in Sepsis and Septic Shock: A Systematic Review, Pairwise, and Dose-Response Meta-Analysis.
   Pitre T, Drover K, Chaudhuri D, Zeraaktkar D, et al · · 2024 · cited 32× · PMID 38250247 · DOI 10.1097/cce.0000000000001000
5. Pediatric Acute Lung Injury and Sepsis Investigators (PALISI): Evolution of an Investigator-Initiated Research Network.
   Randolph AG, Bembea MM, Cheifetz IM, Curley MAQ, et al · · 2022 · cited 30× · PMID 36454002 · DOI 10.1097/pcc.0000000000003100
6. Pediatric sepsis biomarkers for prognostic and predictive enrichment.
   Wong HR. · · 2022 · cited 30× · PMID 34127800 · DOI 10.1038/s41390-021-01620-5
7. Integrated PERSEVERE and endothelial biomarker risk model predicts death and persistent MODS in pediatric septic shock: a secondary analysis of a prospective observational study.
   Atreya MR, Cvijanovich NZ, Fitzgerald JC, Weiss SL, et al · · 2022 · cited 28× · PMID 35818064 · DOI 10.1186/s13054-022-04070-5
8. Hydrocortisone treatment is associated with a longer duration of MODS in pediatric patients with severe sepsis and immunoparalysis.
   Bline KE, Moore-Clingenpeel M, Hensley J, Steele L, et al · · 2020 · cited 10× · PMID 32887651 · DOI 10.1186/s13054-020-03266-x