Dialysis-Less Frequently In The Elderly

NCT ID: NCT03787719

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-27
• Study Completion Date: 2023-11-09

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.

Conditions

Dialysis; End Stage Renal Disease; Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Twice per week dialysis

Twice-weekly 4 hour dialysis treatment (Monday and Friday or Tuesday and Saturday).

Group Type: EXPERIMENTAL

Twice per week dialysis

Intervention Type: OTHER

Twice-weekly 4 hour dialysis treatment

Thrice per week dialysis

Standard thrice-weekly 4 hour dialysis treatment (Monday, Wednesday and Friday or Tuesday, Thursday and Staurday)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Twice per week dialysis

Twice-weekly 4 hour dialysis treatment

Intervention Type: OTHER

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Christine White

OTHER

Sponsor Role: lead

Responsible Party

Dr. Christine White

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Kingston Health Sciences Centre (KHSC)

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

6021932

Identifier Type: -

Identifier Source: org_study_id