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临床试验/NCT04512131
NCT04512131已完成不适用

Impact of Dialysis Modality on Coagulation and Platelet Function in Critically Ill Patients: Intermittent Hemodialysis vs. Continuous Renal Replacement Therapy

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年8月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
clotting time (CT) in EXTEM in rotational thromboelastometry (ROTEM)

研究概览

简要总结

The investigators will evaluate the impact of dialysis modality (intermittent hemodialysis or continuous renal replacement therapy) in coagulation and platelet function in critically ill patients

详细描述

An prospective observational study will be conducted to confirm the impact of two dialysis modalitites on coagulation and platelet function in critically ill patients requiring renal replacement therapy using laboratory test, Multiplate and ROTEM.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Critically ill adult patients in surgical intensive care unit who require renal replacement therapy

排除标准

  • •Patients treated with anti-coagulation therapy due to thrombosis/embolism
  • •Patients who take anti-platelet drug due to cardiac or cerebrovascular diseased
  • •Patients treated with pharmacological prophylaxis of deep vein thrombosis
  • •Patients who received blood products within 24 hours of dialysis initiation
  • •Patients who do not want life-sustaining care including renal replacement therapy

结局指标

主要结局

clotting time (CT) in EXTEM in rotational thromboelastometry (ROTEM)

时间窗: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy

the difference of changes in CT in EXTEM of ROTEM (seconds)

次要结局

  • platelet count(before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy)
  • the amount of blood transfusion(24 hours)
  • hemodynamic changes(24 hours)
  • D-dimer(before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy)
  • Protein S(before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy)
  • Multiplate® platelet function analysis area under curve unit(before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy)
  • clot formation time (CFT) in EXTEM(before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy)
  • Amplitude 10 minutes after CT (A10) in EXTEM(before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy)
  • Maximal clot firmness (MCF) in EXTEM(before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy)
  • α-angle in EXTEM(before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy)
  • prothrombin time(before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy)
  • activated partial thromboplastin time(before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy)
  • fibrinogen(before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy)
  • Protein C(before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy)
  • changes of characteristics or amount of drainage(24 hours)

研究者

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

Ho Geol Ryu

Associate professor

Seoul National University Hospital

研究点 (1)

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