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Corticosteroids to Treat Pancreatitis (CRISP)

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ClinicalTrials.gov Identifier: NCT05160506
Recruitment Status : Not yet recruiting
First Posted : December 16, 2021
Last Update Posted : December 16, 2021
Sponsor:
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center

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
Pancreatitis Pancreatitis, Acute Corticosteroid Hydrocortisone Drug: Hydrocortisone Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : April 2022
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : April 2027


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




Primary Outcome Measures :
  1. Severity of Illness Measure [ Time Frame: Enrollment to 72 hours ]
    Change in Sequential Organ failure Assessment (SOFA) Score over 72 hours


Secondary Outcome Measures :
  1. Respiratory Failure Measure [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05160506


Contacts
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Contact: Michael Donnino, MD 6177542295 mdonnino@bidmc.harvard.edu
Contact: Katherine Berg, MD kberg@bidmc.harvard.edu

Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Michael Donnino, MD Beth Israel Deaconess Medical Center
Publications:
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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: December 16, 2021    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Beth Israel Deaconess Medical Center:
Bedside index of severity in acute pancreatitis
Sequential Organ Failure Assessment
Randomized Controlled Trial
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Hydrocortisone
Anti-Inflammatory Agents