Clinical Trials Directory

Trials / Unknown

UnknownNCT03851185

Combining Bioimpedance and Blood Volume Measurements in Haemodialysis

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

Status
Unknown
Phase
Study type
Observational
Enrollment
160 (estimated)
Sponsor
The Leeds Teaching Hospitals NHS Trust · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Timeline

Start date
2019-02-15
Primary completion
2021-03-31
Completion
2021-03-31
First posted
2019-02-22
Last updated
2019-02-28

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03851185. Inclusion in this directory is not an endorsement.