Clinical trial NCT04268264: A Feasibility Study to Test the Acceptability, Tolerance and Safety of Incremental Haemodialysis
Official title: Effect of Incremental Introduction of Dialysis Versus Standard Care in Patients With End-stage Renal Disease: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Hemodialysis Complication
Morality
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2020-02-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This feasibility study tests if patients find incremental HD acceptable, whether they tolerate the treatment as planned and to evaluate its safety. Over a period of 18-months, 20 participants will be recruited in to the study who are about to start HD therapy for ESRD. The participants will start HD incrementally (incremental HD group) reaching full dose HD over a period of approximately 15 weeks. The outcomes will be compared to a cohort of 40 matched patients who previously started HD in the conventional manner (historical controls, conventional HD group).

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.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* 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:

* Age \< 18
* 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.

Primary outcomes:
measure: Acceptability: Recruitment rate
timeFrame: 6 months
measure: Tolerance: Retention rate
timeFrame: 6 months
measure: Completion rates of non-routine tests
timeFrame: 6 months
Secondary outcomes:
measure: Mortality and cardiovascular event rates
timeFrame: 6 months
measure: Mechanistic 1: Rate of loss of residual renal function in the interventional group
timeFrame: 6 months
measure: Mechanistic 2:Changes in fluid load
timeFrame: 6 months
measure: Mechanistic 3:Quality of life
timeFrame: 6 months
measure: Mechanistic 4: Anaemia control
timeFrame: 6 months
measure: Mechanistic 5: Parathyroid hormone control
timeFrame: 6 months
measure: Mechanistic 6: Cardiac load
timeFrame: 6 months
measure: Safety 1: pre dialysis hyperkalaemia
timeFrame: 6 months
measure: Safety 2: severe hypertension
timeFrame: 6 months
measure: Safety 3: Inter-dialytic weight gain
timeFrame: 6 months
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust
state: East Yorkshire
Study officials:
References: