Early Treatment With Dexamethasone in Mild Acute Pancreatitis
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|ClinicalTrials.gov Identifier: NCT01247961|
Recruitment Status : Withdrawn (Investigator left institution)
First Posted : November 25, 2010
Last Update Posted : December 12, 2016
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
|Condition or disease||Intervention/treatment||Phase|
|Patients With Acute Pancreatitis||Drug: Dexamethasone acetate Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Intravenous Dexamethasone for the Early Treatment of Mild Acute Pancreatitis: A Double-Blind, Randomized, Placebo Controlled Trial|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Experimental: 10 mg intravenous dexamethasone
Subjects randomized to intervention arm will receive single dose of 10 mg intravenous dexamethasone.
Drug: Dexamethasone acetate
10 mg intravenous given as single administration with optional repeat dose after 36 hours.
Placebo Comparator: Placebo
Equal volume of normal saline administered as a single intravenous dose at enrollment.
- Systemic Inflammation (measured by c-reactive protein level) [ Time Frame: 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.
- Safety parameters [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247961
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Bechien U Wu, MD, MPH||Center for Pancreatic Disease, Brigham and Women's Hospital|