跳至主要内容
临床试验/NCT04444765
NCT04444765已完成不适用

Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis (Acetate Free Biofiltration and Bicarbonate-based Intermittent Dialysis) in Critically Ill Patients

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年4月23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
200
试验地点
1
主要终点
Occurence of hemodynamic event

研究概览

简要总结

Acute kidney injury (AKI) affects up to 30% of critically ill patients and is associated with increased rates of mortality. Up to 60% of patients with AKI will ultimately require renal replacement therapy (RRT). Intermittent hemodialysis (IHD) is one of the main methods of RRT worldwide. In IHD-bicar, dialysate is composed by electrolytes, including calcium, and bicarbonate. To avoid calcium carbonate precipitation, dialysate has to be supplemented with acids (citric acid, chloride acid or acetic acid). However, IHD-bicar may be associated with hemodynamic instability or respiratory intolerance, mainly related to the CO2 release in the circulation during IHD (HCO3- <--> CO2 + H2O). Some recent studies showed that acetate free biofiltration (AFB-K), a technique that does not require dialysate acidification, could be associated with better hemodynamic stability and to a lower amount of CO2 delivered to the patients. AFB-K may thus improve the hemodynamic and respiratory tolerance of intermittent RRT in critically ill patients.

详细描述

In this prospective observational study, investigators aim to characterize the hemodynamic and respiratory tolerances of HDI-bicar and AFB-K in critically ill patients requiring RRT.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Patients ≥ 18 years old
  • Invasive monitoring of blood pressure
  • Non opposition to the research
  • Admission to the intensive care unit
  • Need of intermittent hemodialysis

排除标准

  • Sodium bicarbonate infusion
  • Pregnancy or breastfeeding
  • Juridical protection

结局指标

主要结局

Occurence of hemodynamic event

时间窗: From admission to discharge, up to 4 hours

The occurrence of at least one of the following events will be considered a hemodynamic event : * Hypotension (decrease of systolic or mean blood pressures ≥ 15 and ≥ 10% respectively) * Tachycardia (increase of heart beating ≥ 20%) * Cardiac arrythmia (junctional tachycardia, atrial fibrillation, flutter, ventricular tachycardia or fibrillation) * Decrease of the cardiac output ≥ 15% (only in patients with invasive cardiac output monitoring) * Starting (or increase dosing) of norepinephrine ≥ 0.1 µg/kg/min

次要结局

  • Change in the "strong ion difference"(baseline, 4 hours)
  • Change in plasma pH(1 hour after the beginning of dialysis session, up to 4 hours)
  • Change in maximal PaCO2(1 hour after the beginning of dialysis , up to 4 hours)
  • Maximum difference of tcPCO2 and etCO2(From admission to discharge, up to 4 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Hemodynamic and Respiratory Tolerance of... | 临床试验