Not provided
Not provided
Not provided
Not provided
Not provided
Investigator left institution
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This pilot trial will evaluate the following in patients with acute pancreatitis:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 mg intravenous dexamethasone | Experimental | Subjects randomized to intervention arm will receive single dose of 10 mg intravenous dexamethasone. |
|
| Placebo | Placebo Comparator | Equal volume of normal saline administered as a single intravenous dose at enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone acetate | Drug | 10 mg intravenous given as single administration with optional repeat dose after 36 hours. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Age>=18 years
Diagnosis of acute pancreatitis confirmed by at least 2 of the following:
Enrollment within 8 hours of presentation
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bechien U Wu, MD, MPH | Center for Pancreatic Disease, Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
Not provided
| ID | Term |
|---|---|
| C018038 | dexamethasone acetate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Normal saline |
|
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 |