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.
This study is feasibility randomised controlled trial. 50 patients who have newly started on haemodialysis will be recruited into the study from 4 UK centres. Eligible patients will be approached prior to initiation of dialysis or after starting dialysis. The details of the study will be explained to them and a Patient Information sheet will be provided. Interested participants will be invited to the study and a written consent will be obtained. The participants will be randomly allocated to 2 groups. 1. Thrice weekly dialysis (control arm) 2. Incremental dialysis - Twice weekly dialysis to start with and slowly increasing the duration and frequency of dialysis to thrice weekly depending on their native kidney function. All participants will be monitored at least once monthly by performing dialysis related blood tests, urine tests, clinical evaluation, medications, weight, dialysis adequacy, adverse events. Questionnaire involving quality of life, mood, illness intrusiveness, functional status, cognitive function will also be performed. Participants will be recruited in the first year and all participants will be followed up for 12 months. All participants may withdraw at any time without any change in their dialysis care. To ensure independence, the University of Hertfordshire will perform randomisation, and assist with data monitoring and data analysis. A 6 month rate of loss of native kidney function between the 2 groups will be analysed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Thrice weekly dialysis.
Individualised dialysis dose according to native kidney function.
East and North Hertfordshire NHS Trust (incorporating Mount Vernon Cancer Centre)
Stevenage, United Kingdom
RECRUITINGRecruitability
Number of patients potentially eligible for screening during the study period
Time frame: 12 months
Recruitability
Proportion of screened patients who fulfil study criteria.
Time frame: 12 months
Recruitability
Proportion of patients approached who agree to participate in the study.
Time frame: 12 months
Retainability
Proportion of patients randomised who withdraw from the study and the reasons for their withdrawal.
Time frame: 12 months
Protocol Adherence
Proportion of patients who adhere to protocol dialysis frequency.
Time frame: 12 months
Incidence of hospital admissions due to hyperkalemia, fluid overload, lower respiratory tract infection [Safety of the study]
Frequency of hospital admission due to hyperkalemia and fluid overload, and lower respiratory tract infection (LRTI).
Time frame: 12 months
Effect size
Rate of change (mean) of RKF in the first 6 months after randomisation.
Time frame: 6 months after randomisation
Dialysis dose
Dialysis dose measured by eKT/V
Time frame: 6 months after randomisation
Residual kidney function
Residual kidney function measured by eKT/V
Time frame: 6 months after randomisation
Quality of life
Assessed using EQ-5D-5L questionnaire.
Time frame: 12 months
Depression
Assessed using PHQ-9 questionnaire.
Time frame: 12 months
Illness intrusiveness
Assessed using Illness intrusiveness rating scale.
Time frame: 12 months
Changes in cognitive function
Assessed by MOCA tool.
Time frame: 12 months
Functional status
Assessed by Clinical Frailty Score (CFS).
Time frame: 12 months
Incidence of vascular access failures [Safety]
Frequency of vascular access failures and interventions.
Time frame: 12 months
Major Adverse Cardiac Events
Assessed by recording of the frequency of the events.
Time frame: 12 months
Survival
Measured by all-cause mortality
Time frame: 12 months
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