Early Treatment With Dexamethasone in Mild Acute Pancreatitis

NCT01247961 | Withdrawn Phase 2 DMC

• 1 other identifier: 2010P-002192
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot trial will evaluate the following in patients with acute pancreatitis:

1. 1.Safety profile of early treatment with intravenous dexamethasone
2. 2.Impact of dexamethasone on systemic inflammation in patients with acute pancreatitis
3. 3.Provide preliminary data on potential impact of early treatment with steroids on clinical outcomes

Conditions

Patients With Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Safety parameters

  72 hours post-randomization

• Composite clinical outcome

  Up to 14 days from hospital admission

Study Arms (2)

10 mg intravenous dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone acetate

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Dexamethasone acetate DRUG

10 mg intravenous given as single administration with optional repeat dose after 36 hours.

10 mg intravenous dexamethasone

Placebo OTHER

Normal saline

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

dexamethasone acetate

Study Officials

• Bechien U Wu, MD, MPH

  Center for Pancreatic Disease, Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Center for Pancreatic Disease

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 25, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 12, 2016

Record last verified: 2016-12

Locations

US (1)