Clinical trial NCT05160506: Corticosteroids to Treat Pancreatitis
Official title: Corticosteroids to Reduce Inflammation in Severe Pancreatitis: A Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pancreatitis
Pancreatitis, Acute
Corticosteroid
Hydrocortisone
Keywords: Bedside index of severity in acute pancreatitis
Sequential Organ Failure Assessment
Randomized Controlled Trial
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Severity of Illness Measure
timeFrame: Enrollment to 72 hours
Secondary outcomes:
measure: Respiratory Failure Measure
timeFrame: Enrollment to 28 days [truncated at 28 days]
measure: Alive and Ventilator Free Days
timeFrame: Enrollment to 28 days [truncated at 28 days]
measure: Long-term Functional/Quality of Life Measure
timeFrame: 90 days after Enrollment
measure: In-hospital mortality
timeFrame: Enrollment to 90 days [truncated at 90 days]
measure: 28-day mortality
timeFrame: Enrollment to 28 days [truncated at 28 days]
measure: 90-day mortality
timeFrame: Enrollment to 90 days [truncated at 90 days]
measure: Alive and Hospital free days
timeFrame: Enrollment to 28 days [truncated at 28 days]
measure: Severity of Illness Measure Stratified By Predicted Survival (Physician Opinion)
timeFrame: Enrollment to 72 hours
measure: Severity of Illness Measure Stratified By Bedside Index of Severity in Acute Pancreatitis (BISAP) score
timeFrame: Enrollment to 72 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Michael Donnino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grossestreuer AV, Moskowitz A, Andersen LW, Holmberg MJ, Konacki V, Berg KM, Chase M, Cocchi MN, Donnino MW. Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Health-Related Quality of Life in Sepsis. Crit Care Explor. 2020 Nov 23;2(12):e0270. doi: 10.1097/CCE.0000000000000270. eCollection 2020 Dec.
citation: Moskowitz A, Huang DT, Hou PC, Gong J, Doshi PB, Grossestreuer AV, Andersen LW, Ngo L, Sherwin RL, Berg KM, Chase M, Cocchi MN, McCannon JB, Hershey M, Hilewitz A, Korotun M, Becker LB, Otero RM, Uduman J, Sen A, Donnino MW; ACTS Clinical Trial Investigators. Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Organ Injury in Septic Shock: The ACTS Randomized Clinical Trial. JAMA. 2020 Aug 18;324(7):642-650. doi: 10.1001/jama.2020.11946.
citation: Donnino MW, Andersen LW, Berg KM, Chase M, Sherwin R, Smithline H, Carney E, Ngo L, Patel PV, Liu X, Cutlip D, Zimetbaum P, Cocchi MN; Collaborating Authors from the Beth Israel Deaconess Medical Center's Center for Resuscitation Science Research Group. Corticosteroid therapy in refractory shock following cardiac arrest: a randomized, double-blind, placebo-controlled, trial. Crit Care. 2016 Apr 3;20:82. doi: 10.1186/s13054-016-1257-x.