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Corticosteroids to Treat Pancreatitis (CRISP)

Beth Israel Lahey Health logo

Beth Israel Lahey Health

Status and phase

Enrolling
Phase 2

Conditions

Hydrocortisone
Corticosteroid
Pancreatitis, Acute
Pancreatitis

Treatments

Drug: Placebo
Drug: Hydrocortisone

Study type

Interventional

Funder types

Other

Identifiers

NCT05160506
2021P-000803

Details and patient eligibility

About

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.

Full 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.

Enrollment

86 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

86 participants in 2 patient groups, including a placebo group

Hydrocortisone
Experimental group
Description:
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)
Treatment:
Drug: Hydrocortisone
Placebo
Placebo Comparator group
Description:
Patients in this arm will be given matching placebo (50ml 0.9%NACL) by nursing staff every 8 hours for 72 hours (9 administrations)
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Katherine Berg, MD; Michael Donnino, MD

Data sourced from clinicaltrials.gov

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