Corticosteroids for Acute Pancreatitis
(CRISP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing if giving hydrocortisone can help patients with severe acute pancreatitis by reducing inflammation. The goal is to see if this treatment can improve their health and reduce the time they need to stay in the hospital. Hydrocortisone seems to be effective in treating the early inflammation associated with severe acute pancreatitis.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are already taking corticosteroids at a dose greater than 5mg of oral prednisone daily (or equivalent), you may not be eligible to participate.
Is hydrocortisone generally safe for use in humans?
Hydrocortisone has been studied in various animal models for conditions like acute pancreatitis, showing mixed results. While it can reduce mortality in severe cases, it may also exacerbate certain conditions if not administered correctly. Overall, hydrocortisone is generally considered safe in humans when used appropriately, but its effects can vary depending on the specific condition and treatment protocol.12345
How does the drug hydrocortisone differ from other treatments for acute pancreatitis?
Hydrocortisone is unique in treating acute pancreatitis because it can reduce inflammation by suppressing the breakdown of arachidonic acid and cytokine production, which are chemicals that cause inflammation. It has shown effectiveness in reducing mortality in severe cases by addressing the early systemic inflammatory response, which is not a standard approach in current treatments for this condition.12367
What evidence supports the effectiveness of the drug hydrocortisone for treating acute pancreatitis?
Who Is on the Research Team?
Michael W Donnino, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with severe acute pancreatitis, indicated by high lipase levels and a SOFA score ≥3. Participants must be in or heading to intensive care. It's not for those already on >5mg of prednisone (or equivalent), with autoimmune pancreatitis, contraindications to steroids, prisoners, or if pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous hydrocortisone or placebo every 8 hours for 72 hours
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of mortality and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Hydrocortisone
Hydrocortisone is already approved in European Union, United States, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor