Status:
UNKNOWN
Combining Bioimpedance and Blood Volume Measurements in Haemodialysis
Lead Sponsor:
The Leeds Teaching Hospitals NHS Trust
Conditions:
Haemodialysis Complication
Eligibility:
All Genders
18-100 years
Brief 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 k...
Eligibility Criteria
Inclusion
- Cohort 1 - Reference group: This group is intended to represent HD patients who have normal fluid status and normal compartmental fluid volumes.
- Inclusion criteria:
- Ultrafiltration volumes in the preceding two weeks of less than 0.5 litres;
- pre-HD BCM-measured OH \<1.1 litres; pre-HD blood pressure \<140/90.
- Cohort 2 - High BMI group: This group is intended to represent patients with high BMI who routinely finish dialysis with significant fluid depletion, as defined by BCM, without intradialytic symptoms.
- Inclusion criteria:
- BMI\>30 with target weight \> 1.1 kg below normally hydrated weight;
- no recorded symptoms related to fluid removal in the preceding 2 weeks.
- Cohort 3 - Low LTI group: This group is intended to represent patients who have a low LTI and who routinely finish dialysis with a degree of excess fluid as defined by BCM.
- Inclusion criteria:
- LTI \< 10kg/m2 with target weight \> 1.1 kg above normally hydrated weight.
- Cohort 4 - Localised oedema group: This group is intended to represent patients who have localised lower limb oedema.
- Inclusion criteria:
- Oedema as defined by pitting
Exclusion
Key Trial Info
Start Date :
February 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2021
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03851185
Start Date
February 15 2019
End Date
March 31 2021
Last Update
February 28 2019
Active Locations (1)
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1
St James's University Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF