Health TrialsbyHealthPanel

Corticosteroids to Treat Pancreatitis

ConditionsPancreatitisPancreatitis, AcuteCorticosteroidHydrocortisone
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorBeth Israel Deaconess Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hydrocortisone

    Drug

    Hydrocortisone is a steroid (corticosteroid) medication.

  • Placebo

    Drug

    50ml of 0.9% NACL will serve as the placebo

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: HydrocortisoneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Severity of Illness Measure

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

Time frame
Enrollment to 72 hours

Secondary outcomes

1

Respiratory Failure Measure

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

Time frame
Enrollment to 28 days [truncated at 28 days]
2

Alive and Ventilator Free Days

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

Time frame
Enrollment to 28 days [truncated at 28 days]
3

Long-term Functional/Quality of Life Measure

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

Time frame
90 days after Enrollment
4

In-hospital mortality

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

Time frame
Enrollment to 90 days [truncated at 90 days]

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beth Israel Deaconess Medical Center

Lead sponsor

Source ClinicalTrials.gov
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