RecruitingPhase 2NCT05160506

Corticosteroids to Treat Pancreatitis

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


Sponsor

Beth Israel Deaconess Medical Center

Enrollment

86 participants

Start Date

Mar 6, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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

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Interventions

DRUGHydrocortisone

Hydrocortisone is a steroid (corticosteroid) medication.

DRUGPlacebo

50ml of 0.9% NACL will serve as the placebo


Locations(1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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NCT05160506


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