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临床试验/NCT02622854
NCT02622854已完成不适用

Comparison of Plasma Exchange and Conservative Management in Non-severe Acute Hypertriglyceridemic Pancreatitis With Mildly Elevated Triglycerides

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
decrease in triglycerides

研究概览

简要总结

To compare effectiveness in reducing triglycerides between daily plasma exchange and glucose+insulin infusion in patients with non-severe acute hypertriglyceridemic pancreatitis with mildly elevated triglycerides

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • mild acute hypertriglyceridemic pancreatitis
  • triglycerides >15 but < 40 mmol/l

排除标准

  • pregnancy
  • severe course of pancreatitis

研究组 & 干预措施

plasma exchange

Experimental

plasma exchange, with 1.5 estimated plasma volume exchanged with albumin solution, using citrate anticoagulation, performed daily until triglycerides <=10 mmol/l

干预措施: plasma exchange (Procedure)

conservative treatment

Active Comparator

infusion of 5% glucose and insulin, to maintain blood glucose at 5-8 mmol/l

干预措施: conservative treatment (Drug)

结局指标

主要结局

decrease in triglycerides

时间窗: within first 24 h after admission

as % of starting value

次要结局

  • time until triglycerides drop to <10 mmol/l(by the end of hospital stay, up to 100 days)
  • highest C-reactive protein (CRP)(by the end of hospital stay, up to 100 days)
  • % of patients with severe pancreatitis(by the end of hospital stay, up to 100 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jakob Gubensek

MD, PhD

University Medical Centre Ljubljana

研究点 (1)

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