Using hydrocortisone to treat severe acute pancreatitis
Corticosteroids to Reduce Inflammation in Severe Pancreatitis: A Randomized, Controlled Study
This study is testing if giving hydrocortisone to people with severe acute pancreatitis can help them recover faster and spend less time in the hospital.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05160506 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of acute pancreatitis and a SOFA score of 3 or higher.
Not a fit: Patients with autoimmune pancreatitis or those already requiring corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery times and outcomes for patients suffering from severe acute pancreatitis.
How similar studies have performed: While the use of corticosteroids in pancreatitis is a debated topic, this specific approach with intravenous hydrocortisone in a controlled setting is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.