Early Treatment With Dexamethasone in Mild Acute Pancreatitis
NCT ID: NCT01247961
Last Updated: 2016-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2010-11-30
2011-06-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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10 mg intravenous dexamethasone
Subjects randomized to intervention arm will receive single dose of 10 mg intravenous dexamethasone.
Dexamethasone acetate
10 mg intravenous given as single administration with optional repeat dose after 36 hours.
Placebo
Equal volume of normal saline administered as a single intravenous dose at enrollment.
Placebo
Normal saline
Interventions
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Dexamethasone acetate
10 mg intravenous given as single administration with optional repeat dose after 36 hours.
Placebo
Normal saline
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Bechien Wu, MD, MPH
Physician, Center for Pancreatic Disease
Principal Investigators
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Bechien U Wu, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Center for Pancreatic Disease, Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2010P-002192
Identifier Type: -
Identifier Source: org_study_id