Acute Pancreatitis Clinical Trial
— INDOMAPOfficial title:
Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial): Study Protocol for a Multi-center, Double-blinded, Placebo-controlled, Randomized Clinical Trial
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.
Status | Recruiting |
Enrollment | 1428 |
Est. completion date | June 1, 2030 |
Est. primary completion date | June 1, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - All patients ages 18-80 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 |
Country | Name | City | State |
---|---|---|---|
China | Baoding Seventh Hospital | Baoding | Hebei |
China | Liangxiang Hospital | Beijing | Beijing |
China | Peking Union Medical College Hospital | Beijing | Beijing |
China | Peking University Sixth Hospital | Beijing | Beijing |
China | West China Longquan Hospital Sichuan University | Chengdu | Sichuan |
China | Dengzhou People's Hospital | Dengzhou | Henan |
China | Guiyang Second People's Hospital | Guiyang | Guizhou |
China | Fourth Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang |
China | The Second People's Hospital of Huai'an | Huaian | Jiangsu |
China | Jinhua Municipal Central Hospital | Jinhua | Zhejiang |
China | Lishui Municipal Central Hospital | Lishui | Zhejiang |
China | Nantong First People's Hospital | Nantong | Jiangsu |
China | Second People Hospital of Nanyang | Nanyang | Henan |
China | Suqian People's Hospital | Suqian | Jiangsu |
China | The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang |
China | Wuxi Third People's Hospital | Wuxi | Jiangsu |
China | Qinghai University Affiliated Hospital | Xining | Qinghai |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Gorsky VA, Agapov MA, Khoreva MV, Leonenko IV. The effect of lornoxicam on TLR2 and TLR4 messenger RNA expression and tumor necrosis factor-alpha, interleukin-6, and interleukin-8 secretion in patients with systemic complications of acute pancreatitis. Pa — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hospitalization cost | Expense of acute pancreatitis | 1 month | |
Primary | Occurence rate of organ dysfunction | Accumulation of varied organ dysfunction, especially the cardiovascular, renal and respiratory systems | 1 week | |
Secondary | Occurence rate of pancreatic necrosis | Accumulation of the key local complication of acute pancreatitis | 1 month | |
Secondary | Incidence rate of ICU admission | Evaluation of critical severe acute pancreatitis | 1 month | |
Secondary | Mortality | The number of deaths during a particular period of time | 1 month |
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