Does Incremental Initiation of Haemodialysis Preserve Native Kidney Function? (IncrementalHD)
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|ClinicalTrials.gov Identifier: NCT03418181|
Recruitment Status : Unknown
Verified January 2018 by East and North Hertfordshire NHS Trust.
Recruitment status was: Recruiting
First Posted : February 1, 2018
Last Update Posted : February 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Failure Dialysis||Procedure: Standard Haemodialysis Procedure: Incremental dialysis||Not Applicable|
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.
- Thrice weekly dialysis (control arm)
- 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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
The participants will be randomly allocated to 2 groups:
|Masking:||None (Open Label)|
|Official Title:||Does Incremental Initiation of Haemodialysis Preserve Native Kidney Function? A Multicentre Feasibility Randomised Controlled Trial|
|Actual Study Start Date :||January 8, 2018|
|Estimated Primary Completion Date :||January 2, 2019|
|Estimated Study Completion Date :||March 2, 2019|
Thrice weekly dialysis (control arm) - dialysis dose will not be adjusted according to Residual Kidney Function and subjects will be dialysed initially for 3.5-4 hours thrice weekly to ensure a target minimum eKt/V of 1.2.
Procedure: Standard Haemodialysis
Thrice weekly dialysis.
Experimental: Incremental dialysis
Twice weekly dialysis - dialysis dose will be adjusted according to Residual Kidney Function.
Patients will commence dialysis for 3.5-4 hours twice weekly and have residual renal urea clearance formally measured by interdialytic urine collection at the end of the week following dialysis initiation. Subsequent to this, dialysis dose will be adjusted.
Procedure: Incremental dialysis
Individualised dialysis dose according to native kidney function.
- Recruitability [ Time Frame: 12 months ]Number of patients potentially eligible for screening during the study period
- Recruitability [ Time Frame: 12 months ]Proportion of screened patients who fulfil study criteria.
- Recruitability [ Time Frame: 12 months ]Proportion of patients approached who agree to participate in the study.
- Retainability [ Time Frame: 12 months ]Proportion of patients randomised who withdraw from the study and the reasons for their withdrawal.
- Protocol Adherence [ Time Frame: 12 months ]Proportion of patients who adhere to protocol dialysis frequency.
- Incidence of hospital admissions due to hyperkalemia, fluid overload, lower respiratory tract infection [Safety of the study] [ Time Frame: 12 months ]Frequency of hospital admission due to hyperkalemia and fluid overload, and lower respiratory tract infection (LRTI).
- Effect size [ Time Frame: 6 months after randomisation ]Rate of change (mean) of RKF in the first 6 months after randomisation.
- Dialysis dose [ Time Frame: 6 months after randomisation ]Dialysis dose measured by eKT/V
- Residual kidney function [ Time Frame: 6 months after randomisation ]Residual kidney function measured by eKT/V
- Quality of life [ Time Frame: 12 months ]Assessed using EQ-5D-5L questionnaire.
- Depression [ Time Frame: 12 months ]Assessed using PHQ-9 questionnaire.
- Illness intrusiveness [ Time Frame: 12 months ]Assessed using Illness intrusiveness rating scale.
- Changes in cognitive function [ Time Frame: 12 months ]Assessed by MOCA tool.
- Functional status [ Time Frame: 12 months ]Assessed by Clinical Frailty Score (CFS).
- Incidence of vascular access failures [Safety] [ Time Frame: 12 months ]Frequency of vascular access failures and interventions.
- Major Adverse Cardiac Events [ Time Frame: 12 months ]Assessed by recording of the frequency of the events.
- Survival [ Time Frame: 12 months ]Measured by all-cause mortality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418181
|Contact: Dr Enric Vilar||01438 firstname.lastname@example.org|
|Contact: Dr Raja M Kaja Kamalemail@example.com|
|East and North Hertfordshire NHS Trust (incorporating Mount Vernon Cancer Centre)||Recruiting|
|Stevenage, United Kingdom, SG1 4AB|
|Contact: Dr Enric Vilar|
|Principal Investigator:||Dr Enric Vilar||East and North Hertfordshire NHS Trust|