A Trial of Indomethacin in Acute Pancreatitis

Study Overview
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Brief Summary
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Acute pancreatitis (AP) is an inflammatory condition of the pancreas following the activated pancreatic enzymes induced by varied causes, with or without other organ(s) dysfunction. The production and release of inflammatory factors is generally considered as the key factor of pathogenesis. Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly applied agents for inflammatory diseases. A series studies have proved that indomethacin can reduce the risk of post-endoscopic retrograde cholangiopancreatography (ERCP), but high-quality evidence is still lacking in the field of effectiveness of NSAIDs to treat, rather than prevent, other types of AP. Majority of animal experiments showed that NSAIDs had protective effects for organ functions, but the results of several preliminary clinical studies were inconsistent. Randomized controlled trials are eagerly awaited to elucidate its effects on AP.

Official Title
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A Randomized Controlled Trial of Indomethacin in Acute Pancreatitis- Effectiveness and Safety

Conditions
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Acute Pancreatitis, Complication

Intervention / Treatment
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* Drug: Indomethacin SR
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients ages 18-75 years admitted to Peking Union Medical College Hospital (PUMCH) with a diagnosis of AP based on at least 2 of the following criteria: Abdominal pain characteristic of AP Serum amylase and/or lipase ≥ 3 times the upper limit of normal Characteristic findings of AP on abdominal CT scan will be screened for study enrollment. Exclusion Criteria: Onset time >48 hours Presence of renal dysfunction (serum creatinine > 1.5 *normal upper limit) Active peptic ulcer disease or GI bleeding Pregnancy or breast-feeding Use of daily antiplatelet or anticoagulant drug(s) within 2 week of presentation Hypersensitivity to NSAIDs New-onset, exacerbation or uncontrolled hypertension Presence of serious cardiovascular events, including severe heart failure, myocardial infarction (MI) and stroke Mental disability

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indomethacin group<br>Indomethacin SR 50mg q12h from day1 to day 7 plus standard treatment for acute pancreatitis including adequate intravenous fluids, analgesics and early enteral nutrition support if possible. | Drug: Indomethacin SR<br>* Indomethacin SR 50mg given q12h from admission day 1 to day 7<br>* Other names: YINDUOMEIXIN;|
| Sham Comparator: Standard group<br>Similar shape and size suppositories without indomethacin (Placebos) given q12h from admission day 1 to day 7, plus standard treatment for acute pancreatitis including adequate intravenous fluids, analgesics and early enteral nutrition support if possible. | Drug: Placebos<br>* Similar shape and size suppositories (Placebos) without indomethacin given q12h from admission day 1 to day 7<br>* Other names: sham;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence rate of organ dysfunction | Accumulation of varied organ dysfunction, especially the cardiovascular, renal and respiratory systems | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence rate of pancreatic necrosis | Accumulation of the key local complication of acute pancreatitis | 1 month | 
| Incidence rate of ICU admission | Evaluation of critical severe acute pancreatitis | 1 month | 
| Mortality | The number of deaths during a particular period of time | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute pancreatitis, Indomethacin, Prognosis, Organ dysfunction