Corticosteroid, Hydrocortisone, Pancreatitis, Pancreatitis, Acute
Conditions
Keywords
Bedside index of severity in acute pancreatitis, Sequential Organ Failure Assessment, Randomized Controlled Trial
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.
Interventions
DRUGHydrocortisone
Hydrocortisone is a steroid (corticosteroid) medication.
DRUGPlacebo
50ml of 0.9% NACL will serve as the placebo
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The hydrocortisone and placebo solutions are identical in appearance/volume. Only the research pharmacist, (not a member of either the research or clinical teams) will have access to the treatment allocations to ensure blinding of the investigators and clinical staff.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Adult (≥18 years) 2. Acute pancreatitis as defined by a clinical diagnosis of pancreatitis and a lipase level ≥3x the upper limit of normal. 3. Admission or planned admission to an intensive care unit 4. SOFA disease severity score ≥3 (or at least 3 points above a known baseline)
Exclusion criteria
1. Known diagnosis of autoimmune pancreatitis 2. Existing clinical indication for corticosteroids at a dose \>5mg of oral prednisone daily (or equivalent) 3. Contraindication to receiving corticosteroids 4. Protected populations (prisoners) 5. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Illness Measure | Enrollment to 72 hours | Change in Sequential Organ failure Assessment (SOFA) Score over 72 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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 |
| 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. |
| 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. |
| 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) |
Countries
United States
Contacts
CONTACTMichael Donnino, MD
CONTACTKatherine Berg, MD
PRINCIPAL_INVESTIGATORMichael Donnino, MD
Beth Israel Deaconess Medical Center
Outcome results
None listed