NCT05160506PHASE2Recruiting

Corticosteroids to Treat Pancreatitis

Beth Israel Deaconess Medical Center

Start Date

3/6/2022

Completion Date

4/1/2027

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to 99 years

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

Interventions

DRUG

Hydrocortisone

DRUG

Placebo

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Conditions

PancreatitisPancreatitis, AcuteCorticosteroidHydrocortisone

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States