A Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis

• Status: Completed
• Trial end date: 2019-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled pilot trial seeking to evaluate the efficacy of rectal indomethacin in abrogating systemic inflammation and subsequently organ failure and mortality in patients with AP and positive SIRS score.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Treatments: Indomethacin

Criteria

Inclusion Criteria:

• All patients ages 18 or above admitted to UPMC with a diagnosis of AP based on at least 2 of the following criteria:

(i) abdominal pain characteristic of AP (ii) serum amylase and/or lipase ≥ 3 times the upper limit of normal (iii) characteristic findings of AP on abdominal CT scan will be screened for study enrollment.

• Patients with SIRS (≥ 2 of the following criteria: temperature <36°C or >38°C, heart rate >90/min, respiratory rate >20/min OR PaCO2<32 mmHg, WBC <4,000/mm3, >12,000/mm3 or >10% bands) upon hospital admission or who develop SIRS during their first week of hospitalization

Exclusion Criteria:

• Presence of OF (shock defined by SBP<90mmHg, PO2<60mmHg on room air or need for mechanical ventilation, Cr≥2mg/dL)

• Presence of renal dysfunction (Cr>1.5mg/dL)

• Active peptic ulcer disease

• Pregnancy

• Use of daily NSAIDs within 1 week of presentation

• Allergy to NSAIDs.