Patients With Acute Pancreatitis Clinical Trial
Official title:
Intravenous Dexamethasone for the Early Treatment of Mild Acute Pancreatitis: A Double-Blind, Randomized, Placebo Controlled Trial
| Verified date | December 2016 |
| Source | Brigham and Women's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Brigham and Women's Hospital |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | Yes |
| Secondary | 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 | No |