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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
86
Hydrocortisone is a steroid (corticosteroid) medication.
50ml of 0.9% NACL will serve as the placebo
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGSeverity of Illness Measure
Change in Sequential Organ failure Assessment (SOFA) Score over 72 hours
Time frame: Enrollment to 72 hours
Respiratory Failure Measure
Progression to Acute Respiratory Distress Syndrome (ARDS) assessed as a dichotomous variable for those patients without ARDS upon enrollment
Time frame: 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
Time frame: 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.
Time frame: 90 days after Enrollment
In-hospital mortality
Dichotomous variable that assesses whether or not the patient expired prior to hospital discharge
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: Enrollment to 72 hours
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