Early Treatment With Dexamethasone in Mild Acute Pancreatitis

Phase 2

Withdrawn

• Conditions: Patients With Acute Pancreatitis
• Interventions: Drug: Dexamethasone acetate; Other: Placebo

• Registration Number: NCT01247961
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

This pilot trial will evaluate the following in patients with acute pancreatitis:

1. Safety profile of early treatment with intravenous dexamethasone

2. Impact of dexamethasone on systemic inflammation in patients with acute pancreatitis

3. Provide preliminary data on potential impact of early treatment with steroids on clinical outcomes

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-19
• Study First Submitted QC: 2010-11-23
• Study First Posted: 2010-11-25
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-08
• Last Update Posted: 2016-12-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age>=18 years

• Diagnosis of acute pancreatitis confirmed by at least 2 of the following:

  1. Typical epigastric abdominal pain
  2. Elevation amylase/lipase >3 times upper limit normal and/or
  3. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 mg intravenous dexamethasone	Dexamethasone acetate	Subjects randomized to intervention arm will receive single dose of 10 mg intravenous dexamethasone.
Placebo	Placebo	Equal volume of normal saline administered as a single intravenous dose at enrollment.

Primary Outcome Measures

Name	Time	Method
Systemic Inflammation (measured by c-reactive protein level)	48 hours	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.

Secondary Outcome Measures

Name	Time	Method
Safety parameters	72 hours post-randomization	We will monitor for incidence of malignant hyperglycemia (blood sugar\>400 mg/dL), psychosis or culture-documented infectious complications.
Composite clinical outcome	Up to 14 days from hospital admission	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States