Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04721652 |
| Other study ID # |
117983 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 25, 2021 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Lawson Health Research Institute |
| Contact |
Christopher W. McIntyre, MD, PhD |
| Phone |
+1(519)685-8500 |
| Email |
cmcint48[@]uwo.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
