Early Treatment With Dexamethasone in Mild Acute Pancreatitis

• Status: Withdrawn
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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