Acute Pancreatitis Clinical Trials

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

Who is this study for? Patients with Pancreatitis
What treatments are being studied? Hydrocortisone
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Adult (≥18 years)

• Acute pancreatitis as defined by a clinical diagnosis of pancreatitis and a lipase level ≥3x the upper limit of normal.

• Admission or planned admission to an intensive care unit

• SOFA disease severity score ≥3 (or at least 3 points above a known baseline)

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Contact Information
Primary
Michael Donnino, MD
mdonnino@bidmc.harvard.edu
6177542295
Backup
Katherine Berg, MD
kberg@bidmc.harvard.edu
Time Frame
Start Date: 2022-03-06
Estimated Completion Date: 2027-04
Participants
Target number of participants: 86
Treatments
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)
Sponsors
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov