Study of Intravenous Hydrocortisone to Improve Outcomes in Adults With Severe Acute Pancreatitis
Led by Beth Israel Deaconess Medical Center · Updated on 2026-02-18
86
Participants Needed
1
Research Sites
12 weeks
Total Duration
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
Research Team
M
Michael Donnino, MD
K
Katherine Berg, MD
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Hydrocortisone
Placebo
What it is
Hydrocortisone is a corticosteroid medication tested as a potential treatment for severe acute pancreatitis in adults requiring ICU care.
Placebo consists of 50ml saline solution (0.9% NACL), with no active corticosteroid, administered to compare against hydrocortisone treatment.
Role in trial
Intervention arm being evaluated for reduction of disease severity, organ failure, and mortality in severe acute pancreatitis.
Control group for comparison, reflecting current practice without routine corticosteroid use.
Primary use
Investigated for its potential to decrease inflammation, reduce illness severity, and improve outcomes in patients with severe acute pancreatitis.
Used to provide comparison against hydrocortisone, representing standard supportive care without corticosteroid treatment.
How it is given or performed
Hydrocortisone is administered intravenously according to a trial-defined dosing protocol in the ICU.
A matching intravenous saline solution (placebo) is given following the same schedule as hydrocortisone.
Current published evidence
There is no established evidence supporting hydrocortisone for improved outcomes in severe acute pancreatitis; this study is being conducted to determine its potential benefit.
Supportive care without corticosteroids reflects current practice, as published studies to date have not established a benefit for routine steroid use in this setting.
Important limitations
Hydrocortisone's effectiveness and safety for severe acute pancreatitis are not yet known, and possible adverse effects include those typical for corticosteroid use, such as increased infection risk and blood sugar changes.
Placebo group may only receive supportive care practices, as no additional anti-inflammatory intervention is administered.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years - 99Years
All Genders
Eligibility Criteria
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)
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
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
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
Corticosteroids to Reduce Inflammation in Severe Pancreatitis (CRISP) protocol and statistical analysis plan: a prospective, multicentre, double-blind, randomized, placebo controlled clinical trial.