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Early Treatment With Dexamethasone in Mild Acute Pancreatitis

Primary Purpose

Patients With Acute Pancreatitis

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone acetate
Placebo
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Acute Pancreatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

10 mg intravenous dexamethasone

Placebo

Arm Description

Subjects randomized to intervention arm will receive single dose of 10 mg intravenous dexamethasone.

Equal volume of normal saline administered as a single intravenous dose at enrollment.

Outcomes

Primary Outcome Measures

Systemic Inflammation (measured by c-reactive protein level)
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
We will monitor for incidence of malignant hyperglycemia (blood sugar>400 mg/dL), psychosis or culture-documented infectious complications.
Composite clinical outcome
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.

Full Information

First Posted
November 19, 2010
Last Updated
December 8, 2016
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01247961
Brief Title
Early Treatment With Dexamethasone in Mild Acute Pancreatitis
Official Title
Intravenous Dexamethasone for the Early Treatment of Mild Acute Pancreatitis: A Double-Blind, Randomized, Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator left institution
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Acute Pancreatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 mg intravenous dexamethasone
Arm Type
Experimental
Arm Description
Subjects randomized to intervention arm will receive single dose of 10 mg intravenous dexamethasone.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Equal volume of normal saline administered as a single intravenous dose at enrollment.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone acetate
Intervention Description
10 mg intravenous given as single administration with optional repeat dose after 36 hours.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Normal saline
Primary Outcome Measure Information:
Title
Systemic Inflammation (measured by c-reactive protein level)
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Safety parameters
Description
We will monitor for incidence of malignant hyperglycemia (blood sugar>400 mg/dL), psychosis or culture-documented infectious complications.
Time Frame
72 hours post-randomization
Title
Composite clinical outcome
Description
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.
Time Frame
Up to 14 days from hospital admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age>=18 years Diagnosis of acute pancreatitis confirmed by at least 2 of the following: Typical epigastric abdominal pain Elevation amylase/lipase >3 times upper limit normal and/or 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bechien U Wu, MD, MPH
Organizational Affiliation
Center for Pancreatic Disease, Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Early Treatment With Dexamethasone in Mild Acute Pancreatitis

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