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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Christopher W. McIntyre, MD, PhD contact

+1(519)685-8500 ext. 58502

cmcint48@uwo.ca

Canada2 sites, 2 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

    Recruiting

Other trials in Canada

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 groups in NCT04721652
Study groupRoleWhat 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.

  1. T50%IDWG

    Time to achieve ≥50% cumulative interdialytic weight gain (T50%IDWG) from the last hemodialysis treatment

    Measured: Up to one week

  2. Cumulative IDWG% curve

    Shape of cumulative interdialytic weight gain curve (linear vs nonlinear)

    Measured: Up to one week

Secondary outcomes (4)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted25 Jan 2021
  2. Study start25 Feb 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
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

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.

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