Early Treatment With Dexamethasone in Mild Acute Pancreatitis

Study Overview
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Brief Summary
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This pilot trial will evaluate the following in patients with acute pancreatitis: Safety profile of early treatment with intravenous dexamethasone Impact of dexamethasone on systemic inflammation in patients with acute pancreatitis Provide preliminary data on potential impact of early treatment with steroids on clinical outcomes

Official Title
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Intravenous Dexamethasone for the Early Treatment of Mild Acute Pancreatitis: A Double-Blind, Randomized, Placebo Controlled Trial

Conditions
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Patients With Acute Pancreatitis

Intervention / Treatment
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* Drug: Dexamethasone acetate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>=18 years Diagnosis of acute pancreatitis confirmed by at least 2 of the following: Typical epigastric abdominal pain Elevation amylase/lipase >3 times upper limit normal and/or Confirmatory findings on cross-sectional imaging Enrollment within 8 hours of presentation Exclusion Criteria: Class II or greater NYHA heart failure Oxygen dependent COPD Chronic kidney disease>stage 2 Cirrhosis Existing necrosis on abdominal CT Organ dysfunction prior to enrollment Sepsis Acute respiratory distress syndrome Malignancy not in remission for at least 5 years Active drug use Known allergy to dexamethasone Altered mental status Insulin-requiring diabetes Abdominal surgery within 60 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 mg intravenous dexamethasone<br>Subjects randomized to intervention arm will receive single dose of 10 mg intravenous dexamethasone. | Drug: Dexamethasone acetate<br>* 10 mg intravenous given as single administration with optional repeat dose after 36 hours.<br>|
| Placebo Comparator: Placebo<br>Equal volume of normal saline administered as a single intravenous dose at enrollment. | Other: Placebo<br>* Normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic Inflammation (measured by c-reactive protein level) | C-reactive protein (CRP) is a well-established inflammatory prognostic marker in acute pancreatitis. Primary comparison will be between median CRP levels at 48 hours between treatment arms. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety parameters | We will monitor for incidence of malignant hyperglycemia (blood sugar>400 mg/dL), psychosis or culture-documented infectious complications. | 72 hours post-randomization | 
| Composite clinical outcome | A composite clinical endpoint including development of either 1) pancreatic necrosis, 2) persistent organ dysfunction defined according to Atlanta symposium criteria 3) requirement for treatment in an intensive care unit and/or 4) development of culture-documented infection will be used to evaluate impact of treatment with dexamethasone on clinical outcomes in the study population. | Up to 14 days from hospital admission |