Using hydrocortisone to treat severe acute pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether a short course of intravenous hydrocortisone can improve clinical outcomes and reduce hospitalization duration in patients with severe acute pancreatitis. It is a randomized, double-blind, placebo-controlled trial where participants will receive either hydrocortisone or a saline placebo every 8 hours for 72 hours. The study will monitor changes in the Sequential Organ Failure Assessment (SOFA) score and assess biomarkers through blood draws at various time points.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult (≥18 years)
2. Acute pancreatitis as defined by a clinical diagnosis of pancreatitis and a lipase level ≥3x the upper limit of normal.
3. Admission or planned admission to an intensive care unit
4. SOFA disease severity score ≥3 (or at least 3 points above a known baseline)

Exclusion Criteria:

1. Known diagnosis of autoimmune pancreatitis
2. Existing clinical indication for corticosteroids at a dose \>5mg of oral prednisone daily (or equivalent)
3. Contraindication to receiving corticosteroids
4. Protected populations (prisoners)
5. Pregnancy

Where it's running

• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Michael Donnino, MD — Beth Israel Deaconess Medical Center
• Study coordinator: Michael Donnino, MD
• Email: mdonnino@bidmc.harvard.edu
• Phone: 6177542295

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.