Corticosteroids to Treat Pancreatitis

Last updated: February 16, 2026
Sponsor: Beth Israel Deaconess Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

Pancreatitis

Treatment

Hydrocortisone

Placebo

Clinical Study ID

NCT05160506
2021P-000803
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult (≥18 years)

  2. Acute pancreatitis as defined by a clinical diagnosis of pancreatitis and a lipaselevel ≥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

Exclusion Criteria:

  1. Known diagnosis of autoimmune pancreatitis

  2. Existing clinical indication for corticosteroids at a dose >5mg of oral prednisonedaily (or equivalent)

  3. Contraindication to receiving corticosteroids

  4. Protected populations (prisoners)

  5. Pregnancy

Study Design

Total Participants: 86
Treatment Group(s): 2
Primary Treatment: Hydrocortisone
Phase: 2
Study Start date:
March 06, 2022
Estimated Completion Date:
April 30, 2027

Study Description

This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous hydrocortisone on clinical outcomes in patients with severe acute pancreatitis. The interventional drug is Hydrocortisone (100 mg of hydrocortisone in 50 milliliters of saline solution). The placebo is saline and is identical in appearance and volume to the interventional drug. Study drug will be administered intravenously every 8 hours for 72 hours as per standard clinical procedures by nursing staff. The patient's sequential organ failure assessment score (SOFA) will be assessed for changes over time. Blood will be drawn at several time points to assess biomarkers over time.

Connect with a study center

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

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