Corticosteroids to Treat Pancreatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-06

Study Completion Date

2027-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pediatric Longitudinal Cohort Study of Chronic Pancreatitis

NCT03672422

Pancreatitis, Chronic Pancreatitis, Acute

COMPLETED

A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis

NCT05664880

Chronic Pancreatitis

RECRUITING EARLY_PHASE1

A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy

NCT00414908

Chronic Pancreatitis Pancreatectomy Pancreatic Exocrine Insufficiency

COMPLETED PHASE3

Inmediate Feeding Tolerance in Acute Pancreatitis

NCT03354065

Acute Pancreatitis Due to Gallstones

COMPLETED NA

Anti-inflammatory Therapy to Improve Outcomes After TPIAT

NCT02713997

Pancreatitis, Chronic; Diabetes; Transplant

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatitis Pancreatitis, Acute Corticosteroid Hydrocortisone

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hydrocortisone

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)

Group Type EXPERIMENTAL

Hydrocortisone

Intervention Type DRUG

Hydrocortisone is a steroid (corticosteroid) medication.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

50ml of 0.9% NACL will serve as the placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hydrocortisone

Hydrocortisone is a steroid (corticosteroid) medication.

Intervention Type DRUG

Placebo

50ml of 0.9% NACL will serve as the placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cortef Cortisol Hydrocort Normal Saline 0.9% NACL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No