Dialysis-Less Frequently In The Elderly (D-LITE) Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dialysis
- Sponsor
- Dr. Christine White
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Loss to trial completion
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Dr. Christine White
Associate Professor
Queen's University
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
Outcomes
Primary Outcomes
Loss to trial completion
Time Frame: 1 year
Successful loss to trial completion will be defined as = \>50% of randomized patients completing the 12 month trial. Based on our data, the anticipated reasons for loss to trial completion will be death and moving away from the study center.
Recruitment
Time Frame: 1 year
Successful recruitment will be defined as \>3-4 patients/month over 12 months providing informed consent and meeting criteria for randomization.
percent of prescribed treatments completed by patient
Time Frame: 1 year
Successful adherence will be defined as =\> 90% of intervention being adhered to.
Percent of weekly potassium values falling within normal range.
Time Frame: 1 year
Potassium will be measured every week for the duration of the study.
Percent of weekly post hemodialysis weights that are within 1 kg of prescribed dry weight
Time Frame: 1 year
Prescribed and acheived post HD weight will be recorded weekly.
Secondary Outcomes
- Change in Patient's Quality of Life - Using Edmonton Symptom Assessment System (ESAS-R)(1 year)