What side effects are associated with this type of intervention?

The most common treatments for pancreatitis, particularly involving intravenous hydrocortisone, can have several side effects. These include hyperglycemia, increased susceptibility to infections, bone loss and fractures, and neuropsychiatric side effects such as mood swings or insomnia. Additionally, prolonged use of glucocorticoids can lead to adrenal suppression and other systemic effects. It is important for patients to discuss these potential risks with their healthcare provider to manage and mitigate side effects effectively.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments for pancreatitis that focus on anti-inflammatory therapies like intravenous hydrocortisone. The research is ongoing to determine if such treatments can improve clinical outcomes in severe acute pancreatitis by mitigating inflammation. Most treatments for pancreatitis are supportive, including pain management, nutritional support, and addressing the underlying causes.

What other types of research exist?

Promising novel alternatives to intravenous hydrocortisone for pancreatitis patients include biologic agents targeting specific inflammatory pathways, such as IL-1 inhibitors (e.g., anakinra) and IL-6 inhibitors (e.g., tocilizumab). Additionally, small molecule inhibitors like Janus kinase (JAK) inhibitors and phosphodiesterase-4 (PDE4) inhibitors are being explored for their anti-inflammatory effects. These alternatives aim to reduce inflammation with potentially fewer side effects compared to traditional glucocorticoids.

← Back to Search

Corticosteroid

Corticosteroids for Acute Pancreatitis (CRISP Trial)

Phase 2

Recruiting

Led By Michael Donnino, MD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult (≥18 years)

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

Must not have

Known diagnosis of autoimmune pancreatitis

Existing clinical indication for corticosteroids at a dose >5mg of oral prednisone daily (or equivalent)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment to 90 days [truncated at 90 days]

Awards & highlights

All Individual Drugs Already Approved

Approved for 60 Other Conditions

Summary

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.

Who is the study for?

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.

What is being tested?

The study tests whether a short course of intravenous hydrocortisone can improve outcomes and reduce hospital stays in patients with severe acute pancreatitis compared to a placebo. Hydrocortisone is an anti-inflammatory drug that may help control the disease's progression.

What are the potential side effects?

Potential side effects from hydrocortisone could include increased blood sugar levels, mood swings, increased risk of infection, stomach ulcers, trouble sleeping and weight gain. The severity varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have been diagnosed with severe pancreatitis.

Select...

I am currently in or expected to be in intensive care.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with autoimmune pancreatitis.

Select...

I am prescribed more than 5mg of oral prednisone daily.

Select...

I cannot take corticosteroids due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment to 90 days [truncated at 90 days]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment to 90 days [truncated at 90 days]

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to 90 days [truncated at 90 days] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Severity of Illness Measure

Secondary study objectives

28-day mortality

90-day mortality

Alive and Hospital free days

+6 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: HydrocortisoneExperimental Treatment1 Intervention

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)

Group II: PlaceboPlacebo Group1 Intervention

Patients in this arm will be given matching placebo (50ml 0.9%NACL) by nursing staff every 8 hours for 72 hours (9 administrations)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hydrocortisone

FDA approved

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Intravenous hydrocortisone, an anti-inflammatory medication, is used in the treatment of severe acute pancreatitis to reduce inflammation in the body. Inflammation drives the progression of pancreatitis, leading to tissue damage and complications. By administering hydrocortisone, the inflammatory response is dampened, which can help to mitigate disease progression, reduce pain, and improve overall clinical outcomes. This approach is crucial for pancreatitis patients as it aims to decrease the length of hospitalization and prevent severe complications associated with the disease.