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临床试验/NCT05160467
NCT05160467Unknown不适用

Bio Electrical Impedance Analysis to Monitor Fluid Status During Deresuscitation Strategy in Continuous Renal Replacement Therapy: a Proof of Concept Study

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2021年3月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
23
试验地点
1
主要终点
Correlation coefficient between changes in extracellular water volume estimated by BIA and cumulative fluid balance between day 0 and day 5 (mL).

研究概览

简要总结

Fluid overload is a poor prognostic factor in patients undergoing continuous renal replacement therapy in critical care. A strategy of active fluid removal by net ultrafiltration (UFnet) is one of the means to correct it. However, fluid overload is difficult to quantify: weight variations or cumulative fluid balance are easy to use but imprecise and not concordant markers, while reference methods such as isotope dilution are not adapted to daily practice.

Bio electrical impedance analysis (BIA) is used to estimate body composition, including hydration. It is a non-invasive, rapid and painless measurement. It is commonly used in chronic intermittent haemodialysis to estimate dry weight and guide fluid removal, with a demonstrated impact on blood pressure control. This analysis is feasible in the ICU. Fluid overload as defined by BIA correlates with mortality, most notably in acute renal failure and during continuous renal replacement therapy.

We routinely perform multifrequency segmental BIA (InBody S10, Seoul, Korea) in patients with fluid overload in our intensive care department. Since February 2021, we have implemented a protocol to systematically correct fluid overload by inducing negative fluid balance with UFnet in a manner appropriate to tissue perfusion. In this context, we systematically perform a BIA analysis on the day of the beginning of the fluid balance negativation and then every 48 hours during the first five days.

We would like to evaluate the relevance of BIA monitoring in these patients by comparing it to other parameters of evaluation of the volume status usually used.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age higher than 18
  • Protocol directed deresucitation strategy with net ultrafiltration during continuous renal replacement therapy
  • Bioelectrical impedance analysis available for the day of the initiation of the deresuscitation strategy and at day 5" -> "At least two bioelectrical impedance analysis available during the first 5 days of the initiation of the deresuscitation strategy".

排除标准

  • Left ventricular assist device
  • Patient opposition to the use of his health data
  • Invalid bioelectrical impedance analysis
  • Advanced directives to withhold or withdraw life-sustaining treatment

结局指标

主要结局

Correlation coefficient between changes in extracellular water volume estimated by BIA and cumulative fluid balance between day 0 and day 5 (mL).

时间窗: Coefficient correlation between the variation from day 0 to day 5 of extra cellular water and cumulative fluid balance

The extra cellular water is a volumetric value, given automatically by the InBody S10 device. The cumulative fluid balance at day 5 is the sum of the daily fluid balances between day 0 and day 5. Definition of the fluid balance = inputs - outputs : * Inputs = total cumulative volume of: parenteral medication; enteral and parenteral nutrition; maintenance fluid; blood products; fluid bolus therapy * Outputs = total cumulative volume of: diuresis; losses to drain; net ultra filtration

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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