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NCT Number: NCT05160506

Corticosteroids to Treat Pancreatitis

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.

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Key information

Conditions

Pancreatitis Corticosteroid Digestive System Diseases Hydrocortisone Pancreatic Diseases Pancreatitis, Acute

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Jeremy Silverman

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Hydrocortisone

Drug

Hydrocortisone is a steroid (corticosteroid) medication.

Other names: Cortef, Cortisol, Hydrocort

Placebo

Drug

50ml of 0.9% NACL will serve as the placebo

Other names: Normal Saline, 0.9% NACL

Primary outcomes

  1. Severity of Illness Measure

    Time frame: Enrollment to 72 hours

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

Secondary outcomes

  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine Berg, MD

CONTACT

[email protected]

Michael Donnino, MD

CONTACT

[email protected]

6177542295

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

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

Acronym: CRISP

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2021
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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