Chronic Kidney Disease Requiring Chronic DialysisNCT04721652
Fluid Intake After Hemodialysis
An observational study of Chronic Kidney Disease Requiring Chronic Dialysis and Interdialytic Weight Gain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
Trial summary
Interdialytic weight gain determines how much fluid (ultrafiltration) has to be removed during each hemodialysis session. High ultrafiltration volumes stress the organism and lead to a higher risk of death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis, Interdialytic Weight Gain
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- 25 Feb 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this observational study, we will have a sample of approximately 20 patients on chronic thrice weekly HD self-monitor their weight gain and blood pressure during the interdialytic intervals for one week. Demographics, anthropometrics, HD prescription and treatment information will be recorded. Study participants will complete four questionnaires at the first study visit and will then be provided medical grade scales and a blood pressure monitor, and will be asked to prospectively record weight changes and blood pressure at home four times a day for one week using a logbook. Patients with significant residual urinary volume and diabetes mellitus will not be recruited, the latter to remove the bias of blood glucose in determining osmotic thirst.
Who may be able to join
- Age ≥ 18 years
- Thrice weekly maintenance hemodialysis
- Willing and able to provide written informed consent
Who cannot join
- Diabetes Mellitus
- Residual Urinary Volume > 500 ml/day
- Being able to self-monitor one's body weight and blood pressure
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Adam Linton Unit
London, Ontario, N6A 5W9
Christopher W McIntyre, MD/PhD
- Recruiting
Westmount Kidney Care Centre
London, Ontario, N6K 1M6
Christopher W. McIntyre, MD, PhD, 519-685-8500 ext. 58502, cmcint48@uwo.ca
About this study
Official title: Fluid Intake After Hemodialysis: Investigating the Relationship Between Time and Weight Gain During the Interdialytic Interval
Interdialytic weight gain determines how much fluid (ultrafiltration) has to be removed during each hemodialysis session. High ultrafiltration volumes stress the organism and lead to a higher risk of death. Thirst is the main driving factor of interdialytic weight gain, and thirst is mainly driven by salt intake, molecules that increase blood tonicity (such as sugar in diabetics) and fluid loss (such as in dehydration and blood loss). It has been speculated that fluid loss during hemodialysis could increase the sense of thirst immediately following dialysis, but this statement requires further evidence.
Read the detailed description
Overview: In this observational study, we will have a sample of approximately 20 patients on chronic thrice weekly HD self-monitor their weight gain and blood pressure during the interdialytic intervals for one week. Demographics, anthropometrics, HD prescription and treatment information will be recorded. Study participants will complete four questionnaires at the first study visit and will then be provided medical grade scales and a blood pressure monitor, and will be asked to prospectively record weight changes and blood pressure at home four times a day for one week using a logbook.
Patients with significant residual urinary volume and diabetes mellitus will not be recruited, the latter to remove the bias of blood glucose in determining osmotic thirst.
Home Body Weight Monitoring Study participants will be asked to perform daily home body weight monitoring for the duration of the whole study with medical grade scales. Study participants will be asked to monitor their body weight four times per day: upon waking up, between 12:00 and 2:00 pm, between 6:00 and 8:00 pm and at bedtime. Participants will be asked to wear similar clothing for all measurements. Monitoring will start after the first HD session of the week until the first HD session of the following week.
Home Blood Pressure Monitoring Study participants will be asked to perform daily home blood pressure monitoring for the duration of the whole study with a validated, automated device. Participants with an arteriovenous fistula or graft will be asked to measure blood pressure on the arm without the arteriovenous fistula or graft. Study participants will be asked to monitor blood pressure four times per day, concomitantly with their body weight. Study participants will be asked to record three consecutive blood pressure measurements in a sitting position, after 5 minutes of rest in a quiet room. Monitoring will start after the first HD session of the week until the first HD session of the following week.
Daily Reminders Study participants will be given the option to receive a daily reminder phone call for the duration of the whole study, to encourage compliance to the self-monitoring procedures and to encourage reproducibility (e.g. by wearing similar clothing at each measurement) to weighing procedures. The phone calls will be made from an in-hospital office phone by either the research coordinators or the Ph.D. student attached to this study, following a script. Participants can decline the option of receiving daily reminders.
Scored Sodium Questionnaire Dietary sodium intake will be estimated with the Scored Sodium Questionnaire (SSQ)12 on the first study visit, a 10-item food frequency questionnaire to screen for high sodium intake in CKD. A cut-off value of 65 will be used to identify patients with high sodium intake.
Dialysis Thirst Inventory The Dialysis Thirst Inventory (DTI) is a questionnaire developed by Bots et al.13 It is a seven items questionnaire that quantifies the perception of thirst. Each item has a five-point Likert type scale (never = 1, to very often = 5). The scores are summed and provide a DTI score ranging from 7 (no thirst) to 35 (very thirsty). The items are the following: (1) Thirst is a problem for me. (2) I am thirsty during the day. (3) I am thirsty during the night. (4) My social life is influenced because of my thirst feelings; (5) I'm thirsty before dialysis. (6) I am thirsty during dialysis. (7) I am thirsty after dialysis. This questionnaire will be administered on the first study visit.
Xerostomia Inventory The validated Xerostomia Inventory (XI) consists of 11 items, each with a five-point Likert type scale (never=1, to very often=5) to evaluate xerostomia, that is a feeling of dry mouth.14 Examples of items from the XI are "My mouth feels dry...", "I have difficulty in eating dry foods..." and "I sip liquids to aid in swallowing food." The responses to the 11 items result in an individual XI score for each participant that can range from 11 (no dry mouth) to 55 (extremely dry mouth). This questionnaire will be administered on the first study visit.
Minutes to Recovery after HD This is a clinically validated, simple question, as published by Lindsay et al.15 The question is: "How long does it take you to recover from a dialysis session?", to which participants are free to respond by providing exact times to approximate estimates such as "half a day". The final answer will be converted to minutes for analysis purposes. Responses to this question were reported to be highly reproducible over time and correlated with several quality of life questionnaires, mainly pointing towards physical wellbeing rather than mental health. Furthermore, this measure was sensitive enough to show differences in recovery time between different HD prescriptions (standard vs daily vs nocturnal HD). This question will be administered on the first study visit.
Urine collection When applicable, participants will be asked to collect and record their urine volume on the last day of the long interdialytic interval (Sunday for Monday-Wednesday-Friday patients, Monday for Tuesday-Thursday-Saturday patients). Participants will be provided a disposable urine collection container for this purpose. After completing the collection and recording the total urine volume, the participants will dispose of the urine themselves.
Concomitant Medications Throughout the study, all participants will continue to take all medications as prescribed by their clinical care team and will follow any changes to their medication as seen fit.
- Keywords
- Hemodialysis, Interdialytic Weight Gain, Thirst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis Patients (nondiabetic) | Nondiabetic adult hemodialysis patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
T50%IDWG
Time to achieve ≥50% cumulative interdialytic weight gain (T50%IDWG) from the last hemodialysis treatment
Measured: Up to one week
Cumulative IDWG% curve
Shape of cumulative interdialytic weight gain curve (linear vs nonlinear)
Measured: Up to one week
Secondary outcomes (4)
Correlations of T50%IDWG
Correlation between T50%IDWG with comorbid heart failure, ultrafiltration volume, ultrafiltration rate, intradialytic hypotension, minutes to recovery after hemodialysis, dialysate sodium concentration, scored sodium questionnaire, dialysis thirst inventory, xerostomia inventory.
Measured: One week, Interdialytic intervals
Correlations of Nighttime cumulative %IDWG
Correlation between Nighttime cumulative %IDWG with comorbid heart failure, ultrafiltration volume, ultrafiltration rate, intradialytic hypotension, minutes to recovery after hemodialysis, dialysate sodium concentration, scored sodium questionnaire, dialysis thirst inventory, xerostomia inventory.
Measured: One week, Interdialytic intervals
Comparisons between IDWG% curves
Compare prevalence in comorbid heart failure, ultrafiltration volume, ultrafiltration rate, intradialytic hypotension minutes to recovery after hemodialysis, dialysate sodium concentration, scored sodium questionnaire, dialysis thirst inventory, xerostomia inventory in patients with linear vs nonlinear cumulative interdialytic weight gain curve
Measured: One week, Interdialytic intervals
Daytime vs Nighttime cumulative IDWG%
Comparison between Daytime vs Nighttime cumulative interdialytic weight gain %
Measured: One week, Interdialytic intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start25 Feb 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Requiring Chronic 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris McIntyre, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Christopher W. McIntyre, MD, PhD, Principal investigator, London Health Sciences Centre, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721652
- Sponsor's protocol ID
- 117983
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Intake After Hemodialysis: Investigating the Relationship Between Time and Weight Gain During the Interdialytic Interval
- ClinicalTrials.gov ID
- NCT04721652
- Acronym / sponsor ID
- 117983
- Keywords
- Hemodialysis, Interdialytic Weight Gain, Thirst
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jan 2021 (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.
Interdialytic weight gain determines how much fluid (ultrafiltration) has to be removed during each hemodialysis session. High ultrafiltration volumes stress the organism and lead to a higher risk of death. Thirst is the main driving factor of interdialytic weight gain, and thirst is mainly driven by salt intake, molecules that increase blood tonicity (such as sugar in diabetics) and fluid loss (such as in dehydration and blood loss). It has been speculated that fluid loss during hemodialysis could increase the sense of thirst immediately following dialysis, but this statement requires further evidence.
Detailed description
Overview: In this observational study, we will have a sample of approximately 20 patients on chronic thrice weekly HD self-monitor their weight gain and blood pressure during the interdialytic intervals for one week. Demographics, anthropometrics, HD prescription and treatment information will be recorded. Study participants will complete four questionnaires at the first study visit and will then be provided medical grade scales and a blood pressure monitor, and will be asked to prospectively record weight changes and blood pressure at home four times a day for one week using a logbook.
Patients with significant residual urinary volume and diabetes mellitus will not be recruited, the latter to remove the bias of blood glucose in determining osmotic thirst.
Home Body Weight Monitoring Study participants will be asked to perform daily home body weight monitoring for the duration of the whole study with medical grade scales. Study participants will be asked to monitor their body weight four times per day: upon waking up, between 12:00 and 2:00 pm, between 6:00 and 8:00 pm and at bedtime. Participants will be asked to wear similar clothing for all measurements. Monitoring will start after the first HD session of the week until the first HD session of the following week.
Home Blood Pressure Monitoring Study participants will be asked to perform daily home blood pressure monitoring for the duration of the whole study with a validated, automated device. Participants with an arteriovenous fistula or graft will be asked to measure blood pressure on the arm without the arteriovenous fistula or graft. Study participants will be asked to monitor blood pressure four times per day, concomitantly with their body weight. Study participants will be asked to record three consecutive blood pressure measurements in a sitting position, after 5 minutes of rest in a quiet room. Monitoring will start after the first HD session of the week until the first HD session of the following week.
Daily Reminders Study participants will be given the option to receive a daily reminder phone call for the duration of the whole study, to encourage compliance to the self-monitoring procedures and to encourage reproducibility (e.g. by wearing similar clothing at each measurement) to weighing procedures. The phone calls will be made from an in-hospital office phone by either the research coordinators or the Ph.D. student attached to this study, following a script. Participants can decline the option of receiving daily reminders.
Scored Sodium Questionnaire Dietary sodium intake will be estimated with the Scored Sodium Questionnaire (SSQ)12 on the first study visit, a 10-item food frequency questionnaire to screen for high sodium intake in CKD. A cut-off value of 65 will be used to identify patients with high sodium intake.
Dialysis Thirst Inventory The Dialysis Thirst Inventory (DTI) is a questionnaire developed by Bots et al.13 It is a seven items questionnaire that quantifies the perception of thirst. Each item has a five-point Likert type scale (never = 1, to very often = 5). The scores are summed and provide a DTI score ranging from 7 (no thirst) to 35 (very thirsty). The items are the following: (1) Thirst is a problem for me. (2) I am thirsty during the day. (3) I am thirsty during the night. (4) My social life is influenced because of my thirst feelings; (5) I'm thirsty before dialysis. (6) I am thirsty during dialysis. (7) I am thirsty after dialysis. This questionnaire will be administered on the first study visit.
Xerostomia Inventory The validated Xerostomia Inventory (XI) consists of 11 items, each with a five-point Likert type scale (never=1, to very often=5) to evaluate xerostomia, that is a feeling of dry mouth.14 Examples of items from the XI are "My mouth feels dry...", "I have difficulty in eating dry foods..." and "I sip liquids to aid in swallowing food." The responses to the 11 items result in an individual XI score for each participant that can range from 11 (no dry mouth) to 55 (extremely dry mouth). This questionnaire will be administered on the first study visit.
Minutes to Recovery after HD This is a clinically validated, simple question, as published by Lindsay et al.15 The question is: "How long does it take you to recover from a dialysis session?", to which participants are free to respond by providing exact times to approximate estimates such as "half a day". The final answer will be converted to minutes for analysis purposes. Responses to this question were reported to be highly reproducible over time and correlated with several quality of life questionnaires, mainly pointing towards physical wellbeing rather than mental health. Furthermore, this measure was sensitive enough to show differences in recovery time between different HD prescriptions (standard vs daily vs nocturnal HD). This question will be administered on the first study visit.
Urine collection When applicable, participants will be asked to collect and record their urine volume on the last day of the long interdialytic interval (Sunday for Monday-Wednesday-Friday patients, Monday for Tuesday-Thursday-Saturday patients). Participants will be provided a disposable urine collection container for this purpose. After completing the collection and recording the total urine volume, the participants will dispose of the urine themselves.
Concomitant Medications Throughout the study, all participants will continue to take all medications as prescribed by their clinical care team and will follow any changes to their medication as seen fit.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis Patients (nondiabetic) | – | –Nondiabetic adult hemodialysis patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this observational study, we will have a sample of approximately 20 patients on chronic thrice weekly HD self-monitor their weight gain and blood pressure during the interdialytic intervals for one week. Demographics, anthropometrics, HD prescription and treatment information will be recorded. Study participants will complete four questionnaires at the first study visit and will then be provided medical grade scales and a blood pressure monitor, and will be asked to prospectively record weight changes and blood pressure at home four times a day for one week using a logbook. Patients with significant residual urinary volume and diabetes mellitus will not be recruited, the latter to remove the bias of blood glucose in determining osmotic thirst.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Thrice weekly maintenance hemodialysis
- Willing and able to provide written informed consent
Key exclusion criteria (3 listed)
- Diabetes Mellitus
- Residual Urinary Volume > 500 ml/day
- Being able to self-monitor one's body weight and blood pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
T50%IDWG
Time frame: Up to one week
Time to achieve ≥50% cumulative interdialytic weight gain (T50%IDWG) from the last hemodialysis treatment
Cumulative IDWG% curve
Time frame: Up to one week
Shape of cumulative interdialytic weight gain curve (linear vs nonlinear)
4 secondary outcomes
Correlations of T50%IDWG
Time frame: One week, Interdialytic intervals
Correlations of Nighttime cumulative %IDWG
Time frame: One week, Interdialytic intervals
Comparisons between IDWG% curves
Time frame: One week, Interdialytic intervals
Daytime vs Nighttime cumulative IDWG%
Time frame: One week, Interdialytic intervals
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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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.
Christopher W. McIntyre, MD, PhD principal investigator
London Health Sciences Centre, Western University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease Requiring Chronic Dialysis and Interdialytic Weight Gain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites 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: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher W. McIntyre, MD, PhD (+1(519)685-8500 ext. 58502, cmcint48@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T50%IDWG (time frame: Up to one week). The study lists 2 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 4 May 2026.