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临床试验/NCT07751861
NCT07751861已完成不适用

Metabolic Complications Using a Low- Versus High Concentration Citrate Solution for Regional Anticoagulation in Continuous Kidney Replacement Therapy: A Pragmatic Randomized Trial

University Hospital, Antwerp1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
176
试验地点
1
主要终点
Need for additional electrolyte supplementation

研究概览

简要总结

This study is a pragmatic, randomized trial comparing two commercially available citrate solutions to determine their impact on metabolic complications in critically ill patients with acute kidney injury receiving continuous kidney replacement therapy with regional citrate anticoagulation.

详细描述

This study is a pragmatic, randomized trial comparing two commercially available citrate solutions to determine their impact on metabolic complications in critically ill patients with acute kidney injury receiving continuous kidney replacement therapy with regional citrate anticoagulation.

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

  • Any adult patient admitted to the intensive care unit with acute kidney injury requiring continuous kidney replacement therapy

排除标准

  • expected duration of continuous kidney replacement therapy less than 96 hours
  • prior continuous kidney replacement therapy before inclusion
  • a known hypersensitivity to citrate, acute liver failure or liver cirrhosis Child-Pugh C
  • persistent severe hemodynamic shock with decreased lactate clearance
  • a high likelihood of dying within the first 24h after initiation of CKRT
  • preexisting severe electrolyte disorders before CKRT initiation not attributable to Acute kidney injury

研究组 & 干预措施

Lo-RCA

Experimental

Low concentrated citrate solution 18 mmol citrate per liter

干预措施: low concentrated citrate solution (18 mmol/L) (Device)

Hi-RCA

Experimental

High concentrated citrate solution 136 mmol citrate per liter

干预措施: high concentrated citrate solution (136 mmol/L) (Device)

结局指标

主要结局

Need for additional electrolyte supplementation

时间窗: 96 hours

Need for additional electrolyte supplementation : magnesium, phosphate, potassium

次要结局

  • Time course of serum electrolyte concentrations(96 hours)
  • Incidence of electrolyte and acid-base disorders(96 hours)

研究者

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

Walter Verbrugghe

MD

University Hospital, Antwerp

研究点 (1)

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