Corticosteroids to Treat Pancreatitis

NCT05160506 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2021P-000803
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocortisone; Pancreatitis; Pancreatitis, Acute; Corticosteroid

Keywords

Bedside index of severity in acute pancreatitis; Sequential Organ Failure Assessment; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Severity of Illness Measure

  Change in Sequential Organ failure Assessment (SOFA) Score over 72 hours

  Enrollment to 72 hours

Secondary Outcomes (9)

• Respiratory Failure Measure

  Enrollment to 28 days [truncated at 28 days]

• Alive and Ventilator Free Days

  Enrollment to 28 days [truncated at 28 days]

• Long-term Functional/Quality of Life Measure

  90 days after Enrollment

• In-hospital mortality

  Enrollment to 90 days [truncated at 90 days]

• 28-day mortality

  Enrollment to 28 days [truncated at 28 days]

Study Arms (2)

Hydrocortisone

EXPERIMENTAL

Patients in this arm will be administered 100 mg of hydrocortisone in 50 milliliters of saline solution by nursing staff every 8 hours for 72 hours as per standard clinical procedures (9 administrations)

Drug: Hydrocortisone

Placebo

PLACEBO COMPARATOR

Patients in this arm will be given matching placebo (50ml 0.9%NACL) by nursing staff every 8 hours for 72 hours (9 administrations)

Drug: Placebo

Interventions

Hydrocortisone DRUG

Hydrocortisone is a steroid (corticosteroid) medication.

Also known as: Cortef, Cortisol, Hydrocort

Hydrocortisone

Placebo DRUG

50ml of 0.9% NACL will serve as the placebo

Also known as: Normal Saline, 0.9% NACL

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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.

  PMID: 32809003 BACKGROUND

• 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.

  PMID: 27038920 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Pancreatitis

Interventions

Hydrocortisone; Saline Solution

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Michael Donnino, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Donnino, MD

CONTACT

6177542295; mdonnino@bidmc.harvard.edu

Katherine Berg, MD

CONTACT

kberg@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Emergency Medicine

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 16, 2021
• Study Start: March 6, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)