Early Treatment With Dexamethasone in Mild Acute Pancreatitis

Intravenous Dexamethasone for the Early Treatment of Mild Acute Pancreatitis: A Double-Blind, Randomized, Placebo Controlled Trial

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

Study Overview

• Status: Withdrawn
• Conditions: Patients With Acute Pancreatitis
• Intervention / Treatment: Other: Placebo; Drug: Dexamethasone acetate

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety parameters	We will monitor for incidence of malignant hyperglycemia (blood sugar>400 mg/dL), psychosis or culture-documented infectious complications.	72 hours post-randomization
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.	Up to 14 days from hospital admission

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Bechien U Wu, MD, MPH, Center for Pancreatic Disease, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: November 19, 2010
• First Submitted That Met QC Criteria: November 23, 2010
• First Posted (ESTIMATE): November 25, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 12, 2016
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: 2010P-002192