Early Treatment With Dexamethasone in Mild Acute Pancreatitis
|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Recruitment Status : Withdrawn (Investigator left institution)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.
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|