Corticosteroids to Treat Pancreatitis
- Conditions
- PancreatitisPancreatitis, AcuteHydrocortisoneCorticosteroid
- Interventions
- Drug: Placebo
- Registration Number
- NCT05160506
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 86
- 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)
- 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)
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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) Hydrocortisone 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)
- Primary Outcome Measures
Name Time Method Severity of Illness Measure Enrollment to 72 hours Change in Sequential Organ failure Assessment (SOFA) Score over 72 hours
- Secondary Outcome Measures
Name Time Method Severity of Illness Measure Stratified By Predicted Survival (Physician Opinion) Enrollment to 72 hours Sequential Organ failure Assessment (SOFA) Score over 72 hours compared for patients stratified by survival likelihood per physician opinion into three subgroups (likely, unlikely, or uncertain)
Severity of Illness Measure Stratified By Bedside Index of Severity in Acute Pancreatitis (BISAP) score Enrollment to 72 hours Sequential Organ failure Assessment (SOFA) Score over 72 hours compared for patients stratified by BISAP scores into two groups (BISAP ≥3; BISAP \< 3)
In-hospital mortality Enrollment to 90 days [truncated at 90 days] Dichotomous variable that assesses whether or not the patient expired prior to hospital discharge
Alive and Hospital free days Enrollment to 28 days [truncated at 28 days] Number of days in which the patient was alive and not in the hospital.
Respiratory Failure Measure Enrollment to 28 days [truncated at 28 days] Progression to Acute Respiratory Distress Syndrome (ARDS) assessed as a dichotomous variable for those patients without ARDS upon enrollment
Long-term Functional/Quality of Life Measure 90 days after Enrollment Scores from Short Form 36 (SF36), a validated survey used measure health-related quality of life, with higher scores indicating better quality of life.
Alive and Ventilator Free Days Enrollment to 28 days [truncated at 28 days] Number of days during the 28-day period after enrollment in which the patient is alive and does not receive mechanical ventilation
28-day mortality Enrollment to 28 days [truncated at 28 days] Dichotomous variable that indicates whether or not patient expired by the 28-day time-point while enrolled in the trial.
90-day mortality Enrollment to 90 days [truncated at 90 days] Dichotomous variable that indicates whether or not patient expired by the 90-day time-point while enrolled in the trial.
Trial Locations
- Locations (1)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States