DialysisD-LITENCT03787719
Dialysis-Less Frequently In The Elderly
A study testing Twice per week dialysis in people with Dialysis and End Stage Renal Disease, run by Dr. Christine White at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Dialysis, End Stage Renal Disease, Hemodialysis
- What is being tested?
- Twice per week dialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jun 2018to 9 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- Twice per week dialysis
- Keywords
- Twice weekly dialysis, Thrice weekly dialysis, End Stage Renal Disease
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twice per week dialysisOther
Twice-weekly 4 hour dialysis treatment
| Study group | Role | What they receive |
|---|---|---|
| Twice per week dialysis | Experimental | Twice-weekly 4 hour dialysis treatment (Monday and Friday or Tuesday and Saturday). Receives: Other: Twice per week dialysis |
| Thrice per week dialysis | No intervention | Standard thrice-weekly 4 hour dialysis treatment (Monday, Wednesday and Friday or Tuesday, Thursday and Staurday) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Successful recruitment will be defined as >3-4 patients/month over 12 months providing informed consent and meeting criteria for randomization.
Measured: 1 year
percent of prescribed treatments completed by patient
Successful adherence will be defined as => 90% of intervention being adhered to.
Measured: 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.
Measured: 1 year
Percent of weekly potassium values falling within normal range.
Potassium will be measured every week for the duration of the study.
Measured: 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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start27 Jun 2018
- Primary completion11 Sep 2023
- Study completion9 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center pilot study
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Christine White
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Christine White, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787719
- Sponsor's protocol ID
- 6021932
- Acronym
- D-LITE
- Status last verified
- Apr 2024
- First submitted
- 11 Dec 2018
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialysis-Less Frequently In The Elderly (D-LITE) Pilot Study
- ClinicalTrials.gov ID
- NCT03787719
- Acronym / sponsor ID
- D-LITE / 6021932
- Conditions
- Dialysis, End Stage Renal Disease, Hemodialysis
- Keywords
- Twice weekly dialysis, Thrice weekly dialysis, End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Dr. Christine WhiteUniversity, hospital or other
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center pilot study
| Arm | Type | Receives |
|---|---|---|
| Twice per week dialysis | Experimental | Other: Twice per week dialysisTwice-weekly 4 hour dialysis treatment (Monday and Friday or Tuesday and Saturday). |
| Thrice per week dialysis | No intervention | –Standard thrice-weekly 4 hour dialysis treatment (Monday, Wednesday and Friday or Tuesday, Thursday and Staurday) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Twice per week dialysisTwice-weekly 4 hour dialysis treatment | Other | Twice per week dialysis |
Primary outcome
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.
1 secondary outcome
Change in Patient's Quality of Life - Using Edmonton Symptom Assessment System (ESAS-R)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Twice per week dialysis in people with Dialysis and End Stage Renal Disease, run by Dr. Christine White at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.