Early Treatment With Dexamethasone in Mild Acute Pancreatitis

Mass General Brigham

Status and phase: Withdrawn; Phase 2

Conditions: Patients With Acute Pancreatitis

Treatments: Other: Placebo; Drug: Dexamethasone acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT01247961

2010P-002192

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 2 patient groups, including a placebo group

10 mg intravenous dexamethasone

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone acetate

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo