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Early Treatment With Dexamethasone in Mild Acute Pancreatitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Brigham and Women's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01247961
First received: November 19, 2010
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Brigham and Women's Hospital:

Primary Outcome Measures:
  • Systemic Inflammation (measured by c-reactive protein level) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01247961

Contacts
Contact: Bechien U Wu buwu@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Bechien U Wu, MD, MPH         
Sub-Investigator: Darwin L Conwell, MD, MS         
Sub-Investigator: Peter A Banks, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Bechien U Wu, MD, MPH Center for Pancreatic Disease, Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Bechien U Wu, MD, MPH, Center for Pancreatic Disease, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01247961     History of Changes
Other Study ID Numbers: 2010P-002192
Study First Received: November 19, 2010
Last Updated: November 30, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatitis
Digestive System Diseases
Pancreatic Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014