Early Treatment With Dexamethasone in Mild Acute Pancreatitis

Intravenous Dexamethasone for the Early Treatment of Mild Acute Pancreatitis: A Double-Blind, Randomized, Placebo Controlled Trial

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01247961

Enrollment

Registered

2010-11-25

Start date

2010-11-30

Completion date

2011-06-30

Last updated

2016-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Acute Pancreatitis

Brief 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

Interventions

DRUGDexamethasone acetate

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

OTHERPlacebo

Normal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Systemic Inflammation (measured by c-reactive protein level)	48 hours	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.

Secondary

Measure	Time frame	Description
Safety parameters	72 hours post-randomization	We will monitor for incidence of malignant hyperglycemia (blood sugar\>400 mg/dL), psychosis or culture-documented infectious complications.
Composite clinical outcome	Up to 14 days from hospital admission	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026