Phase 3
N=42
A Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis
Acute Pancreatitis
Bottom Line
View on ClinicalTrials.gov: NCT02692391 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Systemic Inflammatory Response Syndrome (SIRS) Score — -0.96; -1 score on a scale — p=0.87
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Indomethacin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systemic Inflammatory Response Syndrome (SIRS) Score |
-0.96; -1 | 0.87 |
| PRIMARY C-Reactive Protein (CRP) Levels. |
-1.43; -2.08 | 0.48 |
| SECONDARY Number of Participants Who Development of Organ Failure |
6; 3 | 0.71 |
| SECONDARY Mortality |
1; 0 | 1.00 |
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.
Eligibility 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 38°C, heart rate >90/min, respiratory rate >20/min OR PaCO2 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 1.5mg/dL)
- Active peptic ulcer disease
- Pregnancy
- Use of daily NSAIDs within 1 week of presentation
- Allergy to NSAIDs.
Data sourced from ClinicalTrials.gov (NCT02692391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.