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).

Timeline

Start

2019-03-11

Primary completion

2026-09-30

Completion

2026-12-31

Publications

• Menon K, Agus MSD, O'Hearn K, Coughlin-Wells K, Choong K, Kazzaz Y, Lee JH, McNally D, Atreya MR, Ramsay T, Watson RS, Wypij D, Zimmerman JJ; Stress Hydrocortisone in Pediatric Septic Shock (SHIPSS) Study Investigators, Canadian Critical Care Trials Group, and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Stress Hydrocortisone in Pediatric Septic Shock: Protocol for a Pragmatic, Multicenter, International, Randomized, Double-Blinded, Placebo-Controlled Interventional Trial. Pediatr Crit Care Med. 2026 Jan 1;27(1):102-113. doi: 10.1097/PCC.0000000000003872. Epub 2025 Nov 26.
• Tasker RC. Pediatric Critical Care Medicine: New Directions for 2026, Volume 27. Pediatr Crit Care Med. 2026 Jan 1;27(1):1-2. doi: 10.1097/PCC.0000000000003874. Epub 2026 Jan 8. No abstract available.
• Basu S, Habet V, Delgado M, Chiu P, Knox D, Thibault E, Shukla A, Harrington E, Bailey V, Lipsitz S, Fu Y, Agus M, Kheir J, Sasaki J, Moynihan K. Adjunctive Corticosteroids for Hypotension in the Pediatric Cardiac ICU: Single-Center Retrospective Study, 2020-2021. Pediatr Crit Care Med. 2025 Jul 1;26(7):e877-e888. doi: 10.1097/PCC.0000000000003757. Epub 2025 May 1.

Drugs

Indications