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Early Treatment With Dexamethasone in Mild Acute Pancreatitis

This study has been withdrawn prior to enrollment.
(Investigator left institution)
Information provided by (Responsible Party):
Bechien Wu, MD, MPH, Brigham and Women's Hospital Identifier:
First received: November 19, 2010
Last updated: December 8, 2016
Last verified: December 2016

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 Intervention Phase
Patients With Acute Pancreatitis Drug: Dexamethasone acetate Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Bechien Wu, MD, MPH, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 0
Study Start Date: November 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01247961

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Bechien U Wu, MD, MPH Center for Pancreatic Disease, Brigham and Women's Hospital
  More Information

Responsible Party: Bechien Wu, MD, MPH, Physician, Center for Pancreatic Disease, Brigham and Women's Hospital Identifier: NCT01247961     History of Changes
Other Study ID Numbers: 2010P-002192
Study First Received: November 19, 2010
Last Updated: December 8, 2016

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
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 processed this record on June 23, 2017