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Completed
NCT03418181
Does Incremental Initiation of Haemodialysis Preserve Native Kidney Function?
Conditions: Kidney Failure, Dialysis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 44
Sponsor: East and North Hertfordshire NHS Trust
Location: East and North Hertfordshire NHS Trust (incorporating Mount Vernon Cancer Centre) Stevenage
Summary
Patients who start haemodialysis usually retain some natural kidney function for months or years after starting dialysis. Even a small amount of this natural kidney function can be helpful in reducing the need for dietary and fluid restriction. There is also good evidence that retaining a small amount of natural kidney function may provide a survival benefit for patients on dialysis.
Most patients who commence haemodialysis start three times per week for 3.5-4 hours per session, irrespective of the amount of natural kidney function they may have. An alternative approach used in some kidney units is to take account of the natural kidney function in prescribing the amount of dialysis. This may allow patients to start treatment needing to spend less time on dialysis or even to start just twice weekly. The amount of dialysis can be adjusted over time as natural kidney function declines. This is called "incremental haemodialysis". Both of these approaches are considered to be standard care although it is not known which approach is more beneficial to patients.
There are some suggestions that the frequency of dialysis may influence the rate of decline of natural kidney function but this need to be tested in a large randomised study. To inform the design of such a study, a smaller scale feasibility study is required.
We intend to randomise fifty new starters on haemodialysis with adequate natural kidney function into two groups - a group who will have dialysis prescribed in the standard fashion - three times weekly for 3.5-4 hours per session or a group who will have an incremental start beginning with twice weekly treatment. We will investigate how many patients have sufficient natural kidney function to be eligible, whether patients are willing to participate and continue in the study, compare the rate of loss of kidney function between groups, and ascertain whether this individualised dialysis approach is less intrusive to patients. The results will be used to design a larger definitive study.
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years
* Advanced renal failure due to underlying primary kidney disease and established as a new starter on haemodialysis within the previous 3 months
* Residual Kidney Function likely to permit twice weekly dialysis as defined by interdialytic urea clearance ≥3ml/min/1.73m2 BSA measured routinely as part of standard care
* Sufficient understanding of the study procedures and requirements including capacity for explicit agreement to be randomised to standard or incremental HD regimens
Exclusion Criteria:
* Planned organ transplantation and already on another interventional trial within 3 months from study screening
* Anticipated requirement for high-volume ultrafiltration on dialysis (e.g. subjects with daily enteral or parenteral nutrition)
* Blood-borne virus positivity
* Subjects unable to comply with requirement for monthly interdialytic urine collection.
* Pregnancy
* Prognosis \
Source: ClinicalTrials.gov (NCT03418181). StuddyBuddy aggregates publicly available trial information.