Corticosteroids to Treat Pancreatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hydrocortisone, Placebo.
- Who it may be relevant to
- Registry conditions: Pancreatitis, Pancreatitis, Acute, Corticosteroid, Hydrocortisone. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Corticosteroids to Reduce Inflammation in Severe Pancreatitis: A Randomized, Controlled Study
Overview
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
- Drug Hydrocortisone
Hydrocortisone is a steroid (corticosteroid) medication. - Drug Placebo
50ml of 0.9% NACL will serve as the placebo
Primary outcome measures
- Severity of Illness Measure [Time frame: Enrollment to 72 hours]
Secondary outcome measures (9)
- Respiratory Failure Measure [Time frame: Enrollment to 28 days [truncated at 28 days]]
- Alive and Ventilator Free Days [Time frame: Enrollment to 28 days [truncated at 28 days]]
- Long-term Functional/Quality of Life Measure [Time frame: 90 days after Enrollment]
- In-hospital mortality [Time frame: Enrollment to 90 days [truncated at 90 days]]
- 28-day mortality [Time frame: Enrollment to 28 days [truncated at 28 days]]
- 90-day mortality [Time frame: Enrollment to 90 days [truncated at 90 days]]
- Alive and Hospital free days [Time frame: Enrollment to 28 days [truncated at 28 days]]
- Severity of Illness Measure Stratified By Predicted Survival (Physician Opinion) [Time frame: Enrollment to 72 hours]
- Severity of Illness Measure Stratified By Bedside Index of Severity in Acute Pancreatitis (BISAP) score [Time frame: Enrollment to 72 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Beth Israel Deaconess Medical Center — Boston
Publications
- 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. PMID 33251516
- 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 1 PMID 32809003
- 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; PMID 27038920
- Vine J, Berlin N, Moskowitz A, Berg KM, Liu X, Balaji L, Donnino MW, Grossestreuer AV. Corticosteroids to Reduce Inflammation in Severe Pancreatitis (CRISP) protocol and statistical analysis plan: a prospective, multicentre, double-blind, randomized, placebo controlled clinical trial. Contemp Clin Trials. 2024 Apr;139:107486. doi: 10.1016/j.cct.2024.107486. Epub 2024 Feb 29. PMID 38431131
Identifiers
NCT: NCT05160506 · 2021P-000803