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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

CRISP Trial Summary

This trialseeks to improve outcomes of severe acute pancreatitis with a short course of anti-inflammatory medication.

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.Check my eligibility

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.See study design

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.

CRISP Trial Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have been diagnosed with severe pancreatitis.

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

CRISP Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Severity of Illness Measure

Secondary outcome measures

28-day mortality

90-day mortality

Alive and Hospital free days

+6 more

CRISP 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

837 Previous Clinical Trials

13,010,186 Total Patients Enrolled

5 Trials studying Pancreatitis

1,234 Patients Enrolled for Pancreatitis

Michael Donnino, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center

6 Previous Clinical Trials

526 Total Patients Enrolled

Media Library

Hydrocortisone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05160506 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment rate of this research endeavor?

"Affirmative. The clinicaltrials.gov entry for this trial shows that it is currently open to enrollment and has been since March 6th 2022, with the last update occurring on November 29th 2022. 86 individuals are needed in total from a single site of recruitment."

Answered by AI

Is enrollment open to seniors for this research project?

"This medical study is open to those between 18 and 99 years of age. For minors, there are 38 trials available while 104 exist for seniors above 65."

Answered by AI

Is this research endeavor currently recruiting participants?

"Data from clinicaltrials.gov confirms that, as of 11/29/2022, this trial is actively recruiting participants since it was first posted on 3/6/2022."

Answered by AI

In what diseases is hydrocortisone usually prescribed?

"Hydrocortisone is typically prescribed to treat ulcerative colitis, however it may also be effective in managing malignant neoplasms, varicella-zoster virus acute retinal necrosis and Crohn disease."

Answered by AI

Has Hydrocortisone achieved regulatory acceptance by the FDA?

"We estimate Hydrocortisone's safety to be a 2 due to the Phase 2 trial data collected thus far, which confirms its security but lacks evidence of efficacy."

Answered by AI

What criteria must an individual meet to be considered a suitable candidate for this experiment?

"To qualify for this research study, individuals should have a diagnosis of pancreatitis and be within the 18 to 99 year old demographic. Approximately 86 people are needed for recruitment."

Answered by AI

Are there any existing reports that discuss the use of Hydrocortisone for medical applications?

"As of now, there are 60 active clinical trials examining the efficacy of Hydrocortisone with 20 at Phase 3. New york City is one common host for these studies, yet across the world, 3054 medical centres are currently running investigations into this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Corticosteroids to Treat Pancreatitis

Michael Donnino 2022. "Corticosteroids to Treat Pancreatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05160506.

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