NCT05936710招募中不适用
Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite (ICU) Using Citrate- vs Acetate-based Dialysate
Centre Hospitalier de Bethune6 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年12月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- To show that the use of a citrate-based dialysate decreases the occurrence of intradialytic hypotension in the ICU compared with an acetate-based dialysate (The rate of sessions with occurence of at least one hemodynamic instability (IHI)).
研究概览
简要总结
During intermittent hemodialysis (IHD), the occurrence of intradialytic hemodynamic instability (IHI) is frequent in ICU and impacted morbidity and mortality. Bicarbonate dialysate buffer improves hemodynamic tolerance compared to acetate dialysate buffer. However, bicarbonate dialysate buffer still contains a lower concentration of acetate, which could contribute to hemodynamic instability. Recently, citrate-based dialysate in bicarbonate hemodialysis instead of acetate have been proposed. They have the appropriate authorizations for routine use. The aim of this study is to compare acetate- vs citrate-based dialysate in terms of hemodynamic tolerance and effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Patient ≥ 18 years old
- •Patient hospitalized in an intensive care unit
- •Patient with acute renal failure defined by a KDIGO stage ≥ 1 and suspected non-obstructive
- •Patient at risk of per dialytic hypotension (capillary refill time ≥ 3 seconds and/or cardiovascular SOFA ≥ 1 and/or lactatemia > 2mmol/L)
- •Indication for Extra Renal Replacement Therapy with IHD.
排除标准
- •Pregnant or breastfeeding woman
- •Known chronic renal insufficiency of any stage
- •Cardio-renal and hepato renal syndrome
- •Unstable hemodynamic state: refractory shock
- •Patient included in another interventional study likely to modify the hemodynamic state
- •Patient deprived of liberty
- •Patient under guardianship or curatorship
- •Patient not affiliated to a social security system
研究组 & 干预措施
Control group
Other
Using acetate-based dialysate
干预措施: ACETATE based dialysate (Device)
Experimental group
Experimental
Using citrate-based dialysate
干预措施: CITRATE based dialysate (Device)
结局指标
主要结局
To show that the use of a citrate-based dialysate decreases the occurrence of intradialytic hypotension in the ICU compared with an acetate-based dialysate (The rate of sessions with occurence of at least one hemodynamic instability (IHI)).
时间窗: day 28
The rate of sessions with occurence of at least one IHI.
次要结局
- Compare between the two groups (acetate- vs citrate-based dialysate) the mortality at day 28 and in ICU;(day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) the length of stay in Intensive Care Unit.(day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) the Length of stay in hospital.(day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) the change in SOFA score between D0 and D7.(day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) the Number of days without dialysis in Intensive Care Unit.(day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) the time to recovery of diuresis > 0.5ml/kg/h.(day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) average, maximum and end-of-session blood and dialysate flow rates.(day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis the rate variation of sodium, magnesium and calcium.(day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) the rate of calcium supplemented between two IHD sessions.(day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) the dialysis dependency at discharge from ICU and hospital.(day 28)
- Evaluate the hemodynamic tolerance(Each dialysis until day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without catecholamine.(day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) the ratio of Kt/V (achieved/prescribed).(day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) UF ratio (UF prescribed/realized)(day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) urea reduction rate (pre-dialysis urea - post-dialysis urea/pre-dialysis urea)(day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in kalemia.(day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without mechanical ventilation.(day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) session duration ratio (duration achieved/prescribed).(day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in creatinine levels.(day 28)
- Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation of pH and bicarbonate level.(day 28)
研究者
研究点 (6)
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