Corticosteroids to Treat Pancreatitis
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Beth Israel Deaconess Medical Center
- Study ID
- NCT05160506
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Corticosteroid
- Hydrocortisone
- Pancreatitis
- Pancreatitis, Acute
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- Hydrocortisone — DRUGHydrocortisone is a steroid (corticosteroid) medication.
- Placebo — DRUG50ml of 0.9% NACL will serve as the placebo
Study Details
This research is being done to determine if the administration of a short course of intravenous hydrocortisone, an anti-inflammatory medication, to patients with severe acute pancreatitis will improve their clinical outcomes and decrease the length of hospitalization. We think that because inflammation in the body drives the progression of pancreatitis, giving a short course of intravenous hydrocortisone may mitigate disease progression and improve clinical outcomes in patients with severe acute pancreatitis.
Key Dates
- Start date
- Mar 6, 2022
- Status verified
- Feb 2026
- Primary completion
- Jan 31, 2027
- Completion
- Apr 30, 2027
Study Design
- Enrollment
- 86 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: HydrocortisonePatients in this arm will be administered 100 mg of hydrocortisone in 50 milliliters of saline solution by nursing staff every 8 hours for 72 hours as per standard clinical procedures (9 administrations)
- Placebo Comparator: PlaceboPatients in this arm will be given matching placebo (50ml 0.9%NACL) by nursing staff every 8 hours for 72 hours (9 administrations)
Primary Outcome Measure
Severity of Illness Measure [ Time Frame: Enrollment to 72 hours ]
Central Contacts
- Michael Donnino, MD6177542295
- Katherine Berg, MD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Jeremy Silverman |
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