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

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ClinicalTrials.gov Identifier: NCT03787719
Recruitment Status : Recruiting
First Posted : December 26, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Christine White, Queen's University

Tracking Information
First Submitted Date  ICMJE December 11, 2018
First Posted Date  ICMJE December 26, 2018
Last Update Posted Date February 26, 2019
Actual Study Start Date  ICMJE June 27, 2018
Estimated Primary Completion Date November 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
Change in Patient's Quality of Life - Using Edmonton Symptom Assessment System (ESAS-R) [ Time Frame: 1 year ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
  • Patient's Quality of Life-ESAS-r [ Time Frame: 1 year ]
    Change in ESAS-r scores over time.
  • Patient's Quality of Life- SF_36 [ Time Frame: 1 year ]
    Change in SF-36 survey scores over time.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dialysis-Less Frequently In The Elderly
Official Title  ICMJE Dialysis-Less Frequently In The Elderly (D-LITE) Pilot Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Single center pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Dialysis
  • End Stage Renal Disease
  • Hemodialysis
Intervention  ICMJE Other: Twice per week dialysis
Twice-weekly 4 hour dialysis treatment
Study Arms  ICMJE
  • Experimental: Twice per week dialysis
    Twice-weekly 4 hour dialysis treatment (Monday and Friday or Tuesday and Saturday).
    Intervention: Other: Twice per week dialysis
  • No Intervention: Thrice per week dialysis
    Standard thrice-weekly 4 hour dialysis treatment (Monday, Wednesday and Friday or Tuesday, Thursday and Staurday)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 21, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 11, 2020
Estimated Primary Completion Date November 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christine White, MD 613-533-3134 cw38@queensu.ca
Contact: Andrew L Nguyen, MSc 613-533-6000 ext 74500 aln4@queensu.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03787719
Other Study ID Numbers  ICMJE 6021932
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Christine White, Queen's University
Study Sponsor  ICMJE Queen's University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Queen's University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP