NCT03342807Unknown4 期
Randomized, Controlled, Multicenter Studies of the Effects of Intravenous Administration of Insulin and Plasma Exchange on Triglyceride Levels in Early Stage of Hypertriglyceridemia-induced Pancreatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 220
- 主要终点
- serum TG
研究概览
简要总结
To investigate an economical and effective way to reduce the level of serum triglyceride in patients with hypertriglyceridemia-induced acute pancreatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult aged 18 to 80 years old;
- •abdominal pain consistent with AP;
- •serum amylase and / or lipase activity is at least 3 times higher than the normal upper limit;
- •abdominal imaging consistent with AP imaging changes.
- •severe hyperlipidemia "fasting serum TG> 1,000 mg/dL (11.2mmol/L)";
- •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;
- •fasting serum TG less than 1,000 mg / dL (11.2mmol / L);
- •acute lipid-induced pancreatitis at the same time combined with other etiologies of acute pancreatitis.
- •the existence of plasma replacement contraindications: serious allergies to plasma, human serum albumin, heparin and others; the existence of mental disorders; unstable heart or cerebral infarction; intracranial hemorrhage or severe cerebral edema associated with hernia.
- •without informed consent, the patient refused to plasma replacement, and other circumstances may bring significant bias.
研究组 & 干预措施
Group Insulin
Experimental
干预措施: Insulin (Drug)
Group Aphesis
Experimental
干预措施: Aphesis (Device)
结局指标
主要结局
serum TG
时间窗: every 4 hours in first 3 days
Elimination of serum triglyceride.
次要结局
未报告次要终点
研究者
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