Corticosteroids to Reduce Inflammation in Severe Pancreatitis: A Randomized, Controlled Study
Overview
- Phase
- Phase 2
- Intervention
- Hydrocortisone
- Conditions
- Pancreatitis
- Sponsor
- Beth Israel Deaconess Medical Center
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Severity of Illness Measure
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
This research is being done to determine if the administration of a short course of intravenous hydrocortisone, an anti-inflammatory medication, to patients with severe acute pancreatitis will improve their clinical outcomes and decrease the length of hospitalization. We think that because inflammation in the body drives the progression of pancreatitis, giving a short course of intravenous hydrocortisone may mitigate disease progression and improve clinical outcomes in patients with severe acute pancreatitis.
Detailed Description
This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous hydrocortisone on clinical outcomes in patients with severe acute pancreatitis. The interventional drug is Hydrocortisone (100 mg of hydrocortisone in 50 milliliters of saline solution). The placebo is saline and is identical in appearance and volume to the interventional drug. Study drug will be administered intravenously every 8 hours for 72 hours as per standard clinical procedures by nursing staff. The patient's sequential organ failure assessment score (SOFA) will be assessed for changes over time. Blood will be drawn at several time points to assess biomarkers over time.
Investigators
Michael Donnino
Professor of Emergency Medicine
Beth Israel Deaconess Medical Center
Eligibility Criteria
Inclusion Criteria
- •Adult (≥18 years)
- •Acute pancreatitis as defined by a clinical diagnosis of pancreatitis and a lipase level ≥3x the upper limit of normal.
- •Admission or planned admission to an intensive care unit
- •SOFA disease severity score ≥3 (or at least 3 points above a known baseline)
Exclusion Criteria
- •Known diagnosis of autoimmune pancreatitis
- •Existing clinical indication for corticosteroids at a dose \>5mg of oral prednisone daily (or equivalent)
- •Contraindication to receiving corticosteroids
- •Protected populations (prisoners)
Arms & Interventions
Hydrocortisone
Patients in this arm will be administered 100 mg of hydrocortisone in 50 milliliters of saline solution by nursing staff every 8 hours for 72 hours as per standard clinical procedures (9 administrations)
Intervention: Hydrocortisone
Placebo
Patients in this arm will be given matching placebo (50ml 0.9%NACL) by nursing staff every 8 hours for 72 hours (9 administrations)
Intervention: Placebo
Outcomes
Primary Outcomes
Severity of Illness Measure
Time Frame: Enrollment to 72 hours
Change in Sequential Organ failure Assessment (SOFA) Score over 72 hours
Secondary Outcomes
- Severity of Illness Measure Stratified By Predicted Survival (Physician Opinion)(Enrollment to 72 hours)
- Severity of Illness Measure Stratified By Bedside Index of Severity in Acute Pancreatitis (BISAP) score(Enrollment to 72 hours)
- In-hospital mortality(Enrollment to 90 days [truncated at 90 days])
- Alive and Hospital free days(Enrollment to 28 days [truncated at 28 days])
- Respiratory Failure Measure(Enrollment to 28 days [truncated at 28 days])
- Long-term Functional/Quality of Life Measure(90 days after Enrollment)
- Alive and Ventilator Free Days(Enrollment to 28 days [truncated at 28 days])
- 28-day mortality(Enrollment to 28 days [truncated at 28 days])
- 90-day mortality(Enrollment to 90 days [truncated at 90 days])