NCT05160506

Corticosteroids to Treat Pancreatitis

Corticosteroids to Reduce Inflammation in Severe Pancreatitis: A Randomized, Controlled Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatitis
• Pancreatitis, Acute
• Corticosteroid
• Hydrocortisone

Interventions

Type	Name	Description
DRUG	Hydrocortisone	Hydrocortisone is a steroid (corticosteroid) medication.
DRUG	Placebo	50ml of 0.9% NACL will serve as the placebo

Timeline

• Start date: 2022-03-06
• Primary completion: 2027-01-01
• Completion: 2027-04-01
• First posted: 2021-12-16
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study