Recruiting
Phase 2

Corticosteroids

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT05160506

Conditions

Pancreatitis

Pancreatitis, Acute

Corticosteroid

Hydrocortisone

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hydrocortisone

Placebo

Study Details

Brief summary:

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.

Conditions

Pancreatitis

Pancreatitis, Acute

Corticosteroid

Hydrocortisone

Study ID

NCT05160506

Start date

Mar 6, 2022

Status verified date

Feb, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

86 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hydrocortisone

Patients 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: Placebo

Patients in this arm will be given matching placebo (50ml 0.9%NACL) by nursing staff every 8 hours for 72 hours (9 administrations)

Interventions

Hydrocortisone

Hydrocortisone is a steroid (corticosteroid) medication.

Placebo

50ml of 0.9% NACL will serve as the placebo

Primary outcome measure

  • Severity of Illness Measure [ Time Frame: Enrollment to 72 hours ]

Central Contacts and Locations

Central contacts

Michael Donnino, MD

6177542295mdonnino@bidmc.harvard.edu

Katherine Berg, MD

kberg@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

  • Bedside index of severity in acute pancreatitis
  • Sequential Organ Failure Assessment
  • Randomized Controlled Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-02-18.