Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial): Study Protocol for a Multi-center, Double-blinded, Placebo-controlled, Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,504
- 试验地点
- 17
- 主要终点
- Occurence rate of organ dysfunction caused by acute pancreatitis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients ages 18-80 years 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.
排除标准
- •Onset time >24 hours
- •Presence of renal dysfunction (serum creatinine > 1.5 *normal upper limit)
- •Severe liver dysfunction
- •Active peptic ulcer disease or GI bleeding
- •Pregnancy or breast-feeding
- •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
- •Malignancy-associated acute pancreatitis
- •Post-ERCP pancreatitis
- •Informed consent not signed
研究组 & 干预措施
Indomethacin group
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.
干预措施: Indomethacin SR (Drug)
Standard group
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.
干预措施: Placebos (Drug)
结局指标
主要结局
Occurence rate of organ dysfunction caused by acute pancreatitis
时间窗: 1 week
Accumulation of varied organ dysfunction, especially the cardiovascular, renal and respiratory systems
次要结局
- Occurence rate of pancreatic necrosis(1 month)
- Incidence rate of ICU admission(1 month)
- Mortality(1 month)
研究者
DONG WU
Professor of Gastroenterology
Peking Union Medical College Hospital