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Early Treatment With Dexamethasone in Mild Acute Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01247961
Recruitment Status : Withdrawn (Investigator left institution)
First Posted : November 25, 2010
Last Update Posted : December 12, 2016
Information provided by (Responsible Party):
Bechien Wu, MD, MPH, 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

Condition or disease Intervention/treatment Phase
Patients With Acute Pancreatitis Drug: Dexamethasone acetate Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
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.
Other: Placebo
Normal saline

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01247961

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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
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Principal Investigator: Bechien U Wu, MD, MPH Center for Pancreatic Disease, Brigham and Women's Hospital
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Responsible Party: Bechien Wu, MD, MPH, Physician, Center for Pancreatic Disease, Brigham and Women's Hospital Identifier: NCT01247961    
Other Study ID Numbers: 2010P-002192
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Pancreatic Diseases
Digestive System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action