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Phase 2
Age: 18Years - 99Years
All Genders
ID05160506

Study of Intravenous Hydrocortisone to Improve Outcomes in Adults With Severe Acute Pancreatitis

Led by Beth Israel Deaconess Medical Center · Updated on 2026-02-18

86

Participants Needed

1

Research Sites

12 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether a short course of intravenous hydrocortisone, an anti-inflammatory medication, can improve clinical outcomes and reduce hospital stay length in patients with severe acute pancreatitis. This randomized, double-blind, placebo-controlled study focuses on patients admitted to intensive care with significant disease severity, aiming to see if reducing inflammation can slow disease progression. Participants receive either hydrocortisone 100 mg in 50 milliliters of saline or a placebo 50 ml of saline administered intravenously every 8 hours for 72 hours, totaling nine doses. Nursing staff deliver the treatments following standard clinical procedures. The study uses a quadruple-blind design where patients, caregivers, investigators, and outcomes assessors do not know the assigned treatment. Throughout the study, researchers assess the Sequential Organ Failure Assessment SOFA score to monitor changes in illness severity. Blood samples are taken at multiple time points to measure biomarkers. Secondary outcomes include respiratory failure, ventilator-free days, mortality rates up to 90 days, hospital-free days, and long-term quality of life measures. The total participation includes up to 90 days of follow-up to evaluate these outcomes and safety.

CONDITIONS

Brief Title

Corticosteroids to Treat Pancreatitis

Research Team

M

Michael Donnino, MD

K

Katherine Berg, MD

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