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CRISP: Corticosteroids to Treat Pancreatitis

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05160506
Collaborator
(none)
86
Enrollment
2
Arms
60
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Corticosteroids to Reduce Inflammation in Severe Pancreatitis: A Randomized, Controlled Study
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2027
Anticipated Study Completion Date :
Apr 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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)

Drug: Hydrocortisone
Hydrocortisone is a steroid (corticosteroid) medication.
Other Names:
  • Cortef
  • Cortisol
  • Hydrocort

    		•
    Placebo Comparator: 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)

    Drug: Placebo
    50ml of 0.9% NACL will serve as the placebo
    Other Names:
  • Normal Saline
  • 0.9% NACL

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Severity of Illness Measure [Enrollment to 72 hours]

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

    Secondary Outcome Measures

    1. Respiratory Failure Measure [Enrollment to 28 days [truncated at 28 days]]

      Progression to Acute Respiratory Distress Syndrome (ARDS) assessed as a dichotomous variable for those patients without ARDS upon enrollment

    2. Alive and Ventilator Free Days [Enrollment to 28 days [truncated at 28 days]]

      Number of days during the 28-day period after enrollment in which the patient is alive and does not receive mechanical ventilation

    3. Long-term Functional/Quality of Life Measure [90 days after Enrollment]

      Scores from Short Form 36 (SF36), a validated survey used measure health-related quality of life, with higher scores indicating better quality of life.

    4. In-hospital mortality [Enrollment to 90 days [truncated at 90 days]]

      Dichotomous variable that assesses whether or not the patient expired prior to hospital discharge

    5. 28-day mortality [Enrollment to 28 days [truncated at 28 days]]

      Dichotomous variable that indicates whether or not patient expired by the 28-day time-point while enrolled in the trial.

    6. 90-day mortality [Enrollment to 90 days [truncated at 90 days]]

      Dichotomous variable that indicates whether or not patient expired by the 90-day time-point while enrolled in the trial.

    7. Alive and Hospital free days [Enrollment to 28 days [truncated at 28 days]]

      Number of days in which the patient was alive and not in the hospital.

    8. Severity of Illness Measure Stratified By Predicted Survival (Physician Opinion) [Enrollment to 72 hours]

      Sequential Organ failure Assessment (SOFA) Score over 72 hours compared for patients stratified by survival likelihood per physician opinion into three subgroups (likely, unlikely, or uncertain)

    9. Severity of Illness Measure Stratified By Bedside Index of Severity in Acute Pancreatitis (BISAP) score [Enrollment to 72 hours]

      Sequential Organ failure Assessment (SOFA) Score over 72 hours compared for patients stratified by BISAP scores into two groups (BISAP ≥3; BISAP < 3)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Beth Israel Deaconess Medical Center

    Investigators

    • Principal Investigator: Michael Donnino, MD, Beth Israel Deaconess Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Michael Donnino, Professor of Emergency Medicine, Beth Israel Deaconess Medical Center
    ClinicalTrials.gov Identifier:
    NCT05160506
    Other Study ID Numbers:
    • 2021P-000803
    First Posted:
    Dec 16, 2021
    Last Update Posted:
    Dec 16, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Michael Donnino, Professor of Emergency Medicine, Beth Israel Deaconess Medical Center
    Bedside index of severity in acute pancreatitis
    Sequential Organ Failure Assessment
    Randomized Controlled Trial
    Additional relevant MeSH terms:
    Pancreatitis
    Hydrocortisone

    Study Results

    No Results Posted as of Dec 16, 2021