Corticosteroids to Treat Pancreatitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Corticosteroids to Reduce Inflammation in Severe Pancreatitis: A Randomized, Controlled Study

Conditions
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Pancreatitis, Pancreatitis, Acute, Corticosteroid, Hydrocortisone

Intervention / Treatment
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* Drug: Hydrocortisone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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) Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrocortisone<br>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) | Drug: Hydrocortisone<br>* Hydrocortisone is a steroid (corticosteroid) medication.<br>* Other names: Hydrocort;|
| Placebo Comparator: Placebo<br>Patients in this arm will be given matching placebo (50ml 0.9%NACL) by nursing staff every 8 hours for 72 hours (9 administrations) | Drug: Placebo<br>* 50ml of 0.9% NACL will serve as the placebo<br>* Other names: 0.9% NACL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Illness Measure | Change in Sequential Organ failure Assessment (SOFA) Score over 72 hours | Enrollment to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Failure Measure | Progression to Acute Respiratory Distress Syndrome (ARDS) assessed as a dichotomous variable for those patients without ARDS upon enrollment | Enrollment to 28 days [truncated at 28 days] | 
| Alive and Ventilator Free Days | Number of days during the 28-day period after enrollment in which the patient is alive and does not receive mechanical ventilation | Enrollment to 28 days [truncated at 28 days] | 
| Long-term Functional/Quality of Life Measure | Scores from Short Form 36 (SF36), a validated survey used measure health-related quality of life, with higher scores indicating better quality of life. | 90 days after Enrollment | 
| In-hospital mortality | Dichotomous variable that assesses whether or not the patient expired prior to hospital discharge | Enrollment to 90 days [truncated at 90 days] | 
| 28-day mortality | Dichotomous variable that indicates whether or not patient expired by the 28-day time-point while enrolled in the trial. | Enrollment to 28 days [truncated at 28 days] | 
| 90-day mortality | Dichotomous variable that indicates whether or not patient expired by the 90-day time-point while enrolled in the trial. | Enrollment to 90 days [truncated at 90 days] | 
| Alive and Hospital free days | Number of days in which the patient was alive and not in the hospital. | Enrollment to 28 days [truncated at 28 days] | 
| Severity of Illness Measure Stratified By Predicted Survival (Physician Opinion) | 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) | Enrollment to 72 hours | 
| Severity of Illness Measure Stratified By Bedside Index of Severity in Acute Pancreatitis (BISAP) score | Sequential Organ failure Assessment (SOFA) Score over 72 hours compared for patients stratified by BISAP scores into two groups (BISAP ≥3; BISAP < 3) | Enrollment to 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bedside index of severity in acute pancreatitis, Sequential Organ Failure Assessment, Randomized Controlled Trial