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临床试验/NCT03851185
NCT03851185Unknown不适用

Individualised Fluid Management in Haemodialysis: Combining Bioimpedance and Absolute Blood Volume Measurements for Improved Clinical Effectiveness and Patient Experience

The Leeds Teaching Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2019年2月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
160
试验地点
1
主要终点
Measurement of post-dialysis blood volume (ABV) in the high BMI group.

研究概览

简要总结

Around 60,000 patients in the UK are being treated for severe kidney failure. The most common treatment is haemodialysis (HD). An important part of HD is removing extra fluid from the body which the kidneys normally remove in urine. Deciding how much fluid to remove is not easy. It is normally based on clinical signs, such as blood pressure or tissue swollen with fluid, but there is a need for better tests to help guide these decisions.

Bioimpedance tests are one way of measuring fluid status. They involve passing a small electric current through tissue using stickers on the skin. The test is portable, cheap, simple, painless and harmless. One bioimpedance device, the Body Composition Monitor (BCM), has been designed particularly for kidney patients. However the BCM measures fluid in the whole body and cannot tell us how much fluid is in the blood (the blood volume), which has the biggest effect on patients' health.

The aim of this study is to see whether blood volume measurements can help to make fluid management more individualised. This could reduce the impact of dialysis on patients' health and improve patients' experience of the treatment.

Objective 1: To demonstrate whether the addition of blood volume measurements can help to tailor fluid management to HD patients' individual needs. In particular we will look at how body size, nutritional state, age and localised fluid can affect patients' blood volume.

Objective 2: To see if there is a simple way of making blood volume measurements with no need for expertise or extra equipment.

It is planned to recruit 40 patients into 4 clinically different groups and compare results between them.

The results will be compared between groups to help us understand how decisions about fluid management can be tailored to keep blood volume at the optimal level.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Measurement of post-dialysis blood volume (ABV) in the high BMI group.

时间窗: 10 mins

Absolute blood volume measurements: ABV measurements will be made based on the infusion of ultra-pure dialysate into the extracorporeal blood circuit and the analysis of the effect of the dilution on RBV.

Measurement of post-dialysis blood volume (ABV) in the localised oedema cohort

时间窗: 10 mins

Absolute blood volume measurements: ABV measurements will be made based on the infusion of ultra-pure dialysate into the extracorporeal blood circuit and the analysis of the effect of the dilution on RBV.

Measurement of post-dialysis blood volume (ABV) in the low lean tissue index (LTI) cohort

时间窗: 10 Mins

Absolute blood volume measurements: ABV measurements will be made based on the infusion of ultra-pure dialysate into the extracorporeal blood circuit and the analysis of the effect of the dilution on RBV.

次要结局

未报告次要终点

研究者

发起方
The Leeds Teaching Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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