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临床试验/NCT03525483
NCT03525483Unknown不适用

Estimation of Glomerular Filtration Flow in Patients of Resuscitation Under Extra-bodily Assistance: Estimation Formula Versus Measured Clearance of Creatinine

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年7月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Compare the clearance of creatinine in urine with GFR

研究概览

简要总结

The aim of the study will be to evaluate the quality of the GFR estimate of the two estimation equations (CKD-EPI and Cockcroft's formula) against the measured clearance of creatinine, which can be performed routinely in intensive care.

To determine the proportion of patients with ARC under ECMO VV or VA and determine changes in renal vascular resistance index as a function of GFR level in patients with pulsatile cardiac output.

详细描述

Extracorporeal assistance is recommended for patients with a potentially reversible acute risk of life that does not respond to conventional treatments. Hypoxic refractory syndromes, such as acute respiratory distress syndrome, are referred to as veno-venous ECMO (for Extracorporeal Membrane Oxygenation) (ECMO VV), whereas terminal cardiac dysfunctions require veno-arterial ECMO (VA ECMO). recovery of function (cardiotropic intoxication), or in the most severe cases, pending transplantation or long-term assistance.

This is a qualified pilot study, as it is the first one interested in evaluating the quality of the GFR estimate of the two estimation equations (CKD-EPI and Cockcroft formula) by relative to the measured clearance of creatinine, a method that can be performed routinely in intensive care, for resuscitation patients under veno-arterial or veno-venous ECMO.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Patients over 18
  • ECMO VV or VA after 48 hours of installation
  • Hemodynamic stability for at least 12 hours
  • Person affiliated or benefiting from a social security scheme
  • Having expressed an express consent OR patient for whom a relative has given express consent

排除标准

  • Hemodynamic instability
  • Chronic renal failure patients receiving dialysis
  • Need for continuous or intermittent extra-renal cleansing
  • Patients under the protection of justice
  • Person participating in another search including an exclusion period still in progress
  • Pregnant or lactating woman

研究组 & 干预措施

Patients with ECMO

Experimental

Patients with circulatory assistance by ECMO Patients are included 48 hours after ECMO VA or VV therapy and after hemodynamic stabilization defined by blood pressure stability and cardiac output for at least 12 hours without significant changes in amine flow.

When stable they will have an Ultrasound for renal resistivity index measurement

干预措施: Ultrasound for renal resistivity index measurement (Diagnostic Test)

结局指标

主要结局

Compare the clearance of creatinine in urine with GFR

时间窗: 1 hour

Measured clearance of creatinine in urine (collected over 3 hours during haemodynamic stabilization of the patient) that will be compared to the Glomerular Filtration Rate(GFR) (estimated according to the Cockcroft and CKD-EPI formulas).

次要结局

  • Number of patients in ECMO with augmented renal clearance (ARC)(1 hour)
  • Index of renal vascular resistance(18 months)
  • Differences in the variable GFR between patients with glomerular hypofiltration(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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