Actively Recruiting

Phase 2
Age: 18Years - 99Years
All Genders
ID05160506

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

Led by Beth Israel Deaconess Medical Center · Updated on 2026-02-18

86

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether a short course of intravenous hydrocortisone, an anti-inflammatory medication, can improve clinical outcomes and reduce hospital stay length in patients with severe acute pancreatitis. This randomized, double-blind, placebo-controlled study focuses on patients admitted to intensive care with significant disease severity, aiming to see if reducing inflammation can slow disease progression. Participants receive either hydrocortisone (100 mg in 50 milliliters of saline) or a placebo (50 ml of saline) administered intravenously every 8 hours for 72 hours, totaling nine doses. Nursing staff deliver the treatments following standard clinical procedures. The study uses a quadruple-blind design where patients, caregivers, investigators, and outcomes assessors do not know the assigned treatment. Throughout the study, researchers assess the Sequential Organ Failure Assessment (SOFA) score to monitor changes in illness severity. Blood samples are taken at multiple time points to measure biomarkers. Secondary outcomes include respiratory failure, ventilator-free days, mortality rates up to 90 days, hospital-free days, and long-term quality of life measures. The total participation includes up to 90 days of follow-up to evaluate these outcomes and safety.

CONDITIONS

Brief Title

Corticosteroids to Treat Pancreatitis

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (18 years or older)
  • Clinical diagnosis of acute pancreatitis with lipase level at least 3 times the upper limit of normal
  • Admission or planned admission to an intensive care unit
  • SOFA disease severity score 3 or higher (or at least 3 points above known baseline)
Not Eligible

You will not qualify if you...

  • Known diagnosis of autoimmune pancreatitis
  • Current clinical indication for corticosteroids at a dose greater than 5 mg oral prednisone daily (or equivalent)
  • Contraindication to receiving corticosteroids
  • Prisoners
  • Pregnancy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 72 hours

Participants receive intravenous hydrocortisone or placebo every 8 hours for 72 hours as per standard clinical procedures by nursing staff.

Approximately 9 administrations over 3 days

Follow-up

Duration - Up to 90 days

Participants are monitored for clinical outcomes, including respiratory function, survival, and quality of life up to 90 days after enrollment.

Visits as per clinical schedule up to 90 days

Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

M

Michael Donnino, MD

K

Katherine Berg, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Organ Injury in Septic Shock: The ACTS Randomized Clinical Trial.

Ari Moskowitz, David T Huang, Peter C Hou...

https://pubmed.ncbi.nlm.nih.gov/32809003

Corticosteroid therapy in refractory shock following cardiac arrest: a randomized, double-blind, placebo-controlled, trial.

Michael W Donnino, Lars W Andersen, Katherine M Berg...

https://pubmed.ncbi.nlm.nih.gov/27038920

Corticosteroids to Reduce Inflammation in Severe Pancreatitis (CRISP) protocol and statistical analysis plan: a prospective, multicentre, double-blind, randomized, placebo controlled clinical trial.

Jacob Vine, Noa Berlin, Ari Moskowitz...

https://pubmed.ncbi.nlm.nih.gov/38431131