RECRUITING

Corticosteroids to Treat Pancreatitis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Corticosteroids to Reduce Inflammation in Severe Pancreatitis: A Randomized, Controlled Study

Quick Facts

Study Start:2022-03-06
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05160506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult (≥18 years)
  2. 2. Acute pancreatitis as defined by a clinical diagnosis of pancreatitis and a lipase level ≥3x the upper limit of normal.
  3. 3. Admission or planned admission to an intensive care unit
  4. 4. SOFA disease severity score ≥3 (or at least 3 points above a known baseline)
  1. 1. Known diagnosis of autoimmune pancreatitis
  2. 2. Existing clinical indication for corticosteroids at a dose \>5mg of oral prednisone daily (or equivalent)
  3. 3. Contraindication to receiving corticosteroids
  4. 4. Protected populations (prisoners)
  5. 5. Pregnancy

Contacts and Locations

Study Contact

Michael Donnino, MD
CONTACT
6177542295
mdonnino@bidmc.harvard.edu
Katherine Berg, MD
CONTACT
kberg@bidmc.harvard.edu

Principal Investigator

Michael Donnino, MD
PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center

Study Locations (Sites)

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

  • Michael Donnino, MD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-06
Study Completion Date2027-04

Study Record Updates

Study Start Date2022-03-06
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Pancreatitis
  • Pancreatitis, Acute
  • Corticosteroid
  • Hydrocortisone