Randomized, Controlled, Open-label Trial of Intravenous Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 主要终点
- Reduction of organ failure
研究概览
简要总结
The aim of this study is to investigate the therapeutic efficacy of intensive insulin in patients with hypertriglyceridemia induced moderate/severe acute pancreatitis on the course and outcome of disease.
详细描述
Hypertriglyceridemia-induced acute pancreatitis occurs in about 1-4% of the cases. It is the third leading cause of pancreatitis after biliary and alcoholic etiology. Hypertriglyceridemia can be caused by primary causes, lipid metabolism disorders and secondary causes.
Hyperlipidemic pancreatitis can be provoked when triglyceride levels (TGL) exceed 11.3 mmol/l (1,000 mg/dl). Except for standard symptomatic treatment, plasmapheresis and insulin have been performed to rapidly reduce TGL and chylomicron levels in the blood.The therapeutic efficacy of intensive insulin, standard insulin, and plasmapheresis in patients with hypertriglyceridemia induced moderate/severe acute pancreatitis on the course and outcome of disease.After acceptance patients will be randomized by random envelope in the 3 groups: Group A: intensive insulin (glycemic control 4.4-6.1mmol/L), Group B: standard insulin (glycemic control 7.8-10.0 mmol/L), and Group C: plasmapheresis.
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
- None
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
- •Diagnosis of hypertriglyceridemia induced acute pancreatitis (AP): Typical pain increase in serum lipase or amylase with serum TG> 1,000 mg/dL (11.3mmol/L) or serum was milky with serum TG> 500 mg/dL(5.65 mmol/L)
- •Onset of abdominal pain within <=48h before admission
- •moderate severe or severe Acute Pancreatitis according to Atlanta criteria
- •except for other AP causes, such as cholelithiasis, alcohol, drugs and so on
排除标准
- •other etiologies other than hyperlipidemia leading to AP
- •at the same time combined with other etiologies of AP
- •appear difficult to reverse respiratory failure, severe systemic circulatory failure, coma and other the endangered symptoms, patients expected to die within 24hours
- •disseminated intravascular coagulation, or patients with severe active bleeding
- •without informed consent, the patient refused to plasma replacement, and other circumstances may bring significant bias.
研究组 & 干预措施
Group A: intensive insulin
Group A: intensive insulin (glycemic control 4.4-6.1mmol/L)
干预措施: Insulin (Drug)
Group B: standard insulin
Group B: standard insulin (glycemic control 7.8-10.0 mmol/L),
干预措施: Insulin (Drug)
Group C: plasmapheresis
Group C: plasmapheresis
干预措施: plasmapheresis (Device)
结局指标
主要结局
Reduction of organ failure
时间窗: From admition to hospital discharge, an average of 2 months
reanl failure, respiratory failure, circulatory failure etal
triglyceride levels
时间窗: From admition to hospital discharge, an average of 2 months
triglyceride levels
Reduction of mortality
时间窗: From admition to hospital discharge, an average of 2 months
Number of participants with fatal outcome during hospitalisation
次要结局
- cytokines in serum, urine(From admition to 7 days)
- Severity Score in CT scan(From admition to 7 days)
- TNF-α in serum, urine(From admition to 7 days)
- insulin dose(From admition to 7 days)
- Clinical Severity Score(From admition to 7 days)
研究者
Meng-Tao Zhou
The director of the department of pancreatitis; the president of First Affiliated Hospital of Wenzhou Medical Univeristy
First Affiliated Hospital of Wenzhou Medical University