Dialysis-Less Frequently In The Elderly (D-LITE)

Dialysis-Less Frequently In The Elderly (D-LITE) Pilot Study

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

Study Overview

• Status: Recruiting
• Conditions: Hemodialysis; End Stage Renal Disease; Dialysis
• Intervention / Treatment: Other: Twice per week dialysis

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine White, MD; Phone Number: 613-533-3134; Email: cw38@queensu.ca
• Study Contact Backup: Name: Andrew L Nguyen, MSc; Phone Number: 74500 613-533-6000; Email: aln4@queensu.ca

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Recruiting
      • Kingston Health Sciences Centre (KHSC)
      • Principal Investigator: Christine White, MD
      • Sub-Investigator: Hasitha Welihinda, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Twice per week dialysis; Twice-weekly 4 hour dialysis treatment (Monday and Friday or Tuesday and Saturday).	Other: Twice per week dialysis; Twice-weekly 4 hour dialysis treatment
NO_INTERVENTION: Thrice per week dialysis; Standard thrice-weekly 4 hour dialysis treatment (Monday, Wednesday and Friday or Tuesday, Thursday and Staurday)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	Successful recruitment will be defined as >3-4 patients/month over 12 months providing informed consent and meeting criteria for randomization.	1 year
percent of prescribed treatments completed by patient	Successful adherence will be defined as => 90% of intervention being adhered to.	1 year
Loss to trial completion	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.	1 year
Percent of weekly potassium values falling within normal range.	Potassium will be measured every week for the duration of the study.	1 year
Percent of weekly post hemodialysis weights that are within 1 kg of prescribed dry weight	Prescribed and acheived post HD weight will be recorded weekly.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient's Quality of Life - Using Edmonton Symptom Assessment System (ESAS-R)	The purpose of the ESAS tool is to help with the assessment of 9 symptoms which includes: pain, tiredness, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath and well-being. The ESAS-R is a semantic differential scale which asks respondents to answer a questionnaire and choose between two opposite position (e.g., "No Pain" or "Worst Possible Pain", "No Tiredness" or "Worst Possible Tiredness", etc). The patient will rate the severity of each symptom from 0 to 10. The lower the value the better the outcome. This study will measure the change in ESAS-r symptoms over time. The ESAS-r is always done on the ESAS-r numerical scale and the results later transferred to the ESAS-r Graph.	1 year

Collaborators and Investigators

• Sponsor: Queen's University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 27, 2018
• Primary Completion (ANTICIPATED): September 11, 2023
• Study Completion (ANTICIPATED): September 11, 2023

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (ACTUAL): December 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: End Stage Renal Disease; Twice weekly dialysis; Thrice weekly dialysis
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 6021932

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No