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临床试验/NCT03329313
NCT03329313招募中2 期

Effects of Variation of Sodium Dialysate in ICU Acute Kiney Injury

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2018年4月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
158
试验地点
1
主要终点
Fluid overload

研究概览

简要总结

Intermittent hemodialysis/diafiltration is a current renal replacement therapy (RRT) institued for ICU patients with AKI. For a better clinical tolerance, iinternational guidelines advise to use cold dialysate, increase duration session, decrease blood and dialysate flows, and increase level of sodium dialysate concentration (≥ 145mmol/l). Indeed, the use of a Na concentration dialysate > 145 mmol/l improves intradialytic hemodynamic tolerance but it may also induce fluid overload by the transfert of sodium from the dialysate compartment to the blood. Yet, fluid overload has been strongly associated with mortality in critically ills. The investigators hypothesized that the use of a level in sodium dialysate at 140 mmol/l with slow low efficiency daily dialysis-filtration (SLEDD-f) will permit a fair intradialytic hemodynamic tolerance without the adverse effect of intradiaclytic Na loading from the dialysate. Two randomized groups of ICU AKI patients treated by SLEDD-f will be compared in terms of intradialytic hemodynamic tolerance and overload accordong to 140 or 145 mmol/l of Na in the dialysate

详细描述

Acute kidney injury (AKI) requiring renal replacement therapy (RRT) occurs in 5 to 6% of critically ill patients and is associated with high mortality and significant health resource utilization. Modalities of RRT currently available include intermittent hemodialysis/diafiltration (IHD/F) and continuous renal replacement therapies. Continuous veno-venous therapies have gained wide application in ICUs, often supplanting IHD because of the belief that it is better tolerated in hemodynamically unstable patients. Previous reports have shown however that intermittent therapies may permit similar hemodynamic tolerance but with specific parameters including dialysate composition. Consequently, international guidelines suggest in ICU AKI the use of intermittent modalities with the use of cold dialysate, increased duration session, decreased blood and dialysate flows, and high level of sodium dialysate concentration (≥ 145mmol/l). Increasing the level of sodium dialysate concentration improves obviously the hemodynamic tolerance but may also result in inflated extracellular volume and fluid overload secondary to sodium transfert from the dialysate compartment to the blood. There is a body of evidence that fluid overload may be harmful to the critically ill, has an adverse impact and worsens outcome.

The aim of the study is therefore to compare perdialytic hemodynamic tolerance and fluid overload after 7 days of SLEDD-f using 2 sodium dialysate concentrations -140 vs 145 mmol/l- in ICU AKI patients. The investigators also planned to evaluate and compare mean ultrafiltration rate by patient, total duration of RRT, fluid overload at RRT weaning, ICU length of stay and 28 days ICU mortality using these 2 levels of sodium dialysate concentration.

Methods: This randomised, single center, prospective and non blinded study is being held in medical ICU at Lapeyronie University Hospital of Montpellier.

Patient more than 18 years old, admitted to the ICU for AKI requiring RRT and with a sSofa score > 5 will be included.

RRT will be an on line predilution SLEDD- with the following parameters: blood flow 200ml/min, dialysate flow 200ml/min, infusate flow 60ml/min, temperature 36°C, membrane polysulfone Fx80. An hemodynamic monitoring will be performed at each dialysis session. Weight, daily input and output and extracellular volume will be monitored during ICU stay.

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
Single (Participant)

盲法说明

simple blind

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Low sodium concentration

Active Comparator

Concentration of sodium in dialysate at 140 mmol/l ( Lowering sodium concentration dialysate)

干预措施: Lowering sodium concentration dialysate (Drug)

High Sodium Concentration

Sham Comparator

Concentration of sodium in dialysate at 145 mmol/l (Highing sodium concentration dialysate)

干预措施: Highing sodium concentration dialysate (Drug)

结局指标

主要结局

Fluid overload

时间窗: day 28

Daily weight measure from the initiation to the weaning of RRT.

次要结局

  • Mean ultrafiltration rate by patient/ session(1 day)
  • Intradialytic hemodynamic tolerance(during the requiring renal replacement therapy (RRT))
  • Fluid overload(1 day)
  • Total duration of RRT(1 day)
  • length of stay(1 day)
  • Mortality rate(28 days of admission)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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