Multicenter, Double-bind, Randomised, Placebo Controlled Study of Ulinastatin in Severe Acute Pancreatitis
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 252
- 试验地点
- 6
- 主要终点
- onset of (multiple) organ failure after randomized
研究概览
简要总结
This study aims to evaluate the effect of ulinastatin in the treatment and prevention of organ failure in severe acute pancreatitis.
详细描述
About 20% of patients with acute pancreatitis have a severe course, and 10-15% of those with severe acute pancreatitis (SAP) die. Despite improvements in intensive care treatment during past few decades, effective therapies for acute pancreatitis are still limited.
Early deaths (within the first week) due to severe acute pancreatitis are generally caused by massive inflammatory responses which result in multiple organ failure. Although the exact mechanisms which trigger the inflammatory processes are not completely understood, it is generally accepted that autodigestion and activated leukocytes play important roles in the pathogenesis of acute pancreatitis. Activation of digestive enzymes causes pancreatic injury and results in an inflammatory response that is out of proportion to the response of other organs to a similar insult. The acute inflammatory response itself causes substantial tissue damage and may progress beyond the pancreas to a systemic inflammatory response syndrome, multi organ failure, or death.
UTI is a multivalent Kunitz-type serine protease inhibitor that is found in human urine and blood, it can stabilize lysosome membrane and inhibit lysosome function, inhibit the various enzymes and inflammatory response. Previous study proved that it protects against SIRS pathophysiology and subsequent organ damage induced via the modulation of the proinflammatory mediator, as well as chemokines. UTI has been widely used for the treatment and prevention of multiple organ failure in China, but there is few randomized, placebo controlled trial on ulinastatin. A large multicenter, randomized study is warranted. In this study, we aim to evaluate the effect of ulinastatin in the treatment and prevention of organ failure in severe acute pancreatitis with regular treatment in an add-on trial.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of severe acute pancreatitis , severe acute pancreatitis adapted from the Atlanta classification:
- •Early Prognostic Signs: Ramson signs ≥3, APACHE II score ≥8 Organ Failure and/or Local Complications: Necrosis, Abscess, Pseudocyst;
- •Admission within 72h after onset of symptoms of pancreatitis
- •18-70 years old
- •Signed the informed consent form
排除标准
- •Pre-existing chronic renal insufficiency requiring hemodialysis or peritoneal dialysis
- •pre existing heart dysfunction or NYHA classification score above III
- •pregnancy or lactation
- •Allergy for ulinastatin
- •Received an investigational drug or device within 90 days prior to entering study
- •serious mentally-ill patients including dementia
- •On the verge of death (estimated to be mortal in 12h).
研究组 & 干预措施
ulinastatin group
Regular treatments plus ulinastatin. Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.
干预措施: ulinastatin (Drug)
placebo group
Regular treatment plus placebo. Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.
干预措施: placebo (Drug)
结局指标
主要结局
onset of (multiple) organ failure after randomized
时间窗: 8 days
multiple organ dysfunction score
时间窗: 8 days
次要结局
- Incidence of complications(8 days, 14 days and 28 days)
- mortality(8 days, 14 days and 28 days)
- APACHE Ⅱ score(8 days)
- Need for surgical intervention(From admission to discharge)
- CT-scan score(8 days, 14 days)
- Hospital stay and ICU stay(From admission to discharge)