Clinical trial NCT03787719: Dialysis-Less Frequently In The Elderly
Official title: Dialysis-Less Frequently In The Elderly (D-LITE) Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dialysis
End Stage Renal Disease
Hemodialysis
Keywords: Twice weekly dialysis
Thrice weekly dialysis
End Stage Renal Disease
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 49
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center pilot study
Primary purpose: TREATMENT

Brief summary: Thrice-weekly dialysis is the accepted standard of care for hemodialysis (HD) patients. Observational studies suggest that elderly HD patients do as well and have better quality of life with less dialysis (ie twice-weekly). We propose a single-center pilot study of 40 patients to determine the feasibility of a large randomized controlled trial (RCT) designed to determine the impact of HD frequency on well-being in new HD patients above the age of 70. The primary outcomes will be metrics of feasibility and safety. We hypothesize that an adequately powered RCT that will determine whether elderly patients who dialyze twice weekly have improved well-being compared to thrice-weekly is feasible

Detailed description: This single-center pilot study of 40 patients is designed to determine the feasibility and safety of a large randomized controlled trial examining the impact of hemodialysis frequency on well-being, a patient reported outcome, in incident patients with end stage kidney disease who are above the age of 70. Subjects meeting inclusion criteria will be enrolled into the trial if they are still alive 7 weeks post HD initiation. Once enrolled, subjects will continue thrice weekly HD, have weekly potassium measured, have intra-dialytic weight gain and dry weight assessed weekly and have any extra or missed HD sessions and death recorded. Six weeks post enrollment, subjects meeting inclusion for randomization (potassium within normal range on K2,3 or 4 bath and mean inter-dialytic weight gain of less than 2 L and within 1.0 kg of their prescribed dry weight on weeks 5 and 6) will have residual GFR measured by iohexol clearance and by the average of 48 hour urea and creatinine clearance. Randomization will be 1:1 using permuted blocks of undisclosed varying size and stratified by residual kidney function (RKF) (\<5 ml/min, 5-10 ml/min and \>10 ml/min) measured by the average of 48 hour urea and creatinine clearance. Throughout the remaining 9 months, potassium will be measured weekly, interdialytic weight gain recorded, and missed or extra HD sessions and death will be recorded. Every 6 weeks, ESAs-r and every 3 months the SF-36 will be completed. The primary outcome for this single-center pilot study will be metrics of feasibility and safety. Feasibility will be assessed by rate of enrollment into the trial and rate of subsequent randomization to a treatment arm, adherence to protocol and loss to trial completion. Safety will be assessed by measures of serum potassium and achievement of target weight. We hypothesize that an adequately powered RCT (The D-LITE Main Trial) that will determine whether elderly patients who dialyze twice weekly have better self-reported well-being compared to thrice weekly will be feasible.

Eligibility criteria: Inclusion Criteria:

* Greater than equal 70 years old, planned ongoing in-center HD treatment
* Incident HD patient and still alive 7 weeks post HD initiation
* Patient or substitute decision maker provide informed consent

Exclusion Criteria:

* Significant barriers to ascertainment of the patient-reported experience measures
* Patient currently admitted to hospital without Alternate Level of Care designation
* Patient non-adherent to dialysis prescription

Primary outcomes:
measure: Recruitment
timeFrame: 1 year
measure: percent of prescribed treatments completed by patient
timeFrame: 1 year
measure: Loss to trial completion
timeFrame: 1 year
measure: Percent of weekly potassium values falling within normal range.
timeFrame: 1 year
measure: Percent of weekly post hemodialysis weights that are within 1 kg of prescribed dry weight
timeFrame: 1 year
Secondary outcomes:
measure: Change in Patient's Quality of Life - Using Edmonton Symptom Assessment System (ESAS-R)
timeFrame: 1 year
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre (KHSC)
state: Ontario
Study officials:
References: