A Feasibility Study to Test the Acceptability, Tolerance and Safety of Incremental Haemodialysis
NCT ID: NCT04268264
Last Updated: 2022-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2019-05-01
2022-02-28
Brief Summary
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All patients will be followed-up for 6 months after first dialysis. Participants will be reviewed regularly during this time, and will undergo laboratory and bed-site monitoring tests. Acceptability and tolerance will be tested by documenting the numbers and percentages of patients who agree to participate and continue in the study. Patients who decline the invitation to join the study will be given the opportunity to express their reasons for declining to go on incremental HD (they will not play further part in the study). The safety of incremental HD will be tested by comparing the rates of pre-defined safety events in the incremental HD vs. conventional HD groups.
The impact of incremental HD on patients' residual renal function will be monitored using serial 24-hour urine collections, bio-impedance testing will be conducted to estimate changes in fluid load, measurements of quality-of-life will be undertaken by using patient KDQOL-SF v1.3 questionnaires. These tests will be repeated at regular intervals. Blood tests for estimation of residual renal function and markers of renal anemia, bone disease and cardiac load will be performed at regular intervals and will be compared between the two groups (incremental HD vs. conventional HD groups). These measurements will help in the evaluation of impact of incremental HD on patients' health and well-being. The completion rates of these tests will provide important information about whether they should be included in a future larger trial of incremental HD. Participants undergoing incremental HD will be invited to take part in semi-structured interviews aimed at exploring patients' experiences of receiving incremental HD and their participation in the study.
Data from this study will be used to test if it is feasible to use deaths (or a combination of deaths and cardiovascular events) as the main outcome measure in a future definitive trial on incremental HD. The data should enable a sample-size calculation for a future full-scale trial.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment arm
Will receive trial intervention, Incremental haemodialysis (n=20)
Incremental haemodialysis
twice weekly haemodilysis at the start, gradually building up to full dose dialysis over a period of 15 weeks
Control arm
Historical controls. Matched controls from database of historical patients receiving conventional, three times weekly haemodialysis treatment (n=40)
Conventional haemodialysis
three times weekly 4-hour long haemodialysis sessions from the start
Interventions
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Incremental haemodialysis
twice weekly haemodilysis at the start, gradually building up to full dose dialysis over a period of 15 weeks
Conventional haemodialysis
three times weekly 4-hour long haemodialysis sessions from the start
Eligibility Criteria
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Inclusion Criteria
* patients with CKD-5 who are about to start planned HD
* At least 3 months of prior specialist renal follow-up at the time of starting HD
* Able to meet all the study requirements
* Written signed informed consent.
Exclusion Criteria
* No prior contact with nephrologists for \> 3 months
* Cross-over in to HD from peritoneal dialysis
* Currently undergoing HD therapy
* Any condition which in the opinion of the investigator makes the participant unsuitable for entry in to the study
* Participation in an interventional study in the preceding 6 weeks
* History of myocardial infarction in the preceding 3 months
* Inability to provide informed consent
* Inability to comply with the study schedule and follow-up.
18 Years
ALL
No
Sponsors
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Hull University Teaching Hospitals NHS Trust
OTHER_GOV
Responsible Party
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Locations
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Hull University Teaching Hospitals NHS Trust
Hull, East Yorkshire, United Kingdom
Countries
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Other Identifiers
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R2338
Identifier Type: -
Identifier Source: org_study_id
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