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.
Brief Title
Corticosteroids to Treat 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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
6177542295
Central Contact Email
mdonnino@bidmc.harvard.edu
Central Contact Role
Contact
Central Contact Email
kberg@bidmc.harvard.edu
Completion Date
Completion Date Type
Estimated
Conditions
Pancreatitis
Pancreatitis, Acute
Corticosteroid
Hydrocortisone
Eligibility Criteria
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
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
Inclusion Criteria
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)
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)
Gender
All
Gender Based
false
Keywords
Bedside index of severity in acute pancreatitis
Sequential Organ Failure Assessment
Randomized Controlled Trial
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
99 Years
Minimum Age
18 Years
NCT Id
NCT05160506
Org Class
Other
Org Full Name
Beth Israel Deaconess Medical Center
Org Study Id
2021P-000803
Overall Status
Recruiting
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Corticosteroids to Reduce Inflammation in Severe Pancreatitis: A Randomized, Controlled Study
Primary Outcomes
Outcome Description
Change in Sequential Organ failure Assessment (SOFA) Score over 72 hours
Outcome Measure
Severity of Illness Measure
Outcome Time Frame
Enrollment to 72 hours
Secondary Outcomes
Outcome Description
Progression to Acute Respiratory Distress Syndrome (ARDS) assessed as a dichotomous variable for those patients without ARDS upon enrollment
Outcome Time Frame
Enrollment to 28 days [truncated at 28 days]
Outcome Measure
Respiratory Failure Measure
Outcome Description
Number of days during the 28-day period after enrollment in which the patient is alive and does not receive mechanical ventilation
Outcome Time Frame
Enrollment to 28 days [truncated at 28 days]
Outcome Measure
Alive and Ventilator Free Days
Outcome Description
Scores from Short Form 36 (SF36), a validated survey used measure health-related quality of life, with higher scores indicating better quality of life.
Outcome Time Frame
90 days after Enrollment
Outcome Measure
Long-term Functional/Quality of Life Measure
Outcome Description
Dichotomous variable that assesses whether or not the patient expired prior to hospital discharge
Outcome Time Frame
Enrollment to 90 days [truncated at 90 days]
Outcome Measure
In-hospital mortality
Outcome Description
Dichotomous variable that indicates whether or not patient expired by the 28-day time-point while enrolled in the trial.
Outcome Time Frame
Enrollment to 28 days [truncated at 28 days]
Outcome Measure
28-day mortality
Outcome Description
Dichotomous variable that indicates whether or not patient expired by the 90-day time-point while enrolled in the trial.
Outcome Time Frame
Enrollment to 90 days [truncated at 90 days]
Outcome Measure
90-day mortality
Outcome Description
Number of days in which the patient was alive and not in the hospital.
Outcome Time Frame
Enrollment to 28 days [truncated at 28 days]
Outcome Measure
Alive and Hospital free days
Outcome Description
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)
Outcome Time Frame
Enrollment to 72 hours
Outcome Measure
Severity of Illness Measure Stratified By Predicted Survival (Physician Opinion)
Outcome Description
Sequential Organ failure Assessment (SOFA) Score over 72 hours compared for patients stratified by BISAP scores into two groups (BISAP ≥3; BISAP \< 3)
Outcome Time Frame
Enrollment to 72 hours
Outcome Measure
Severity of Illness Measure Stratified By Bedside Index of Severity in Acute Pancreatitis (BISAP) score
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
99
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ari Moskowitz
Investigator Email
amoskowitz@montefiore.org