Fluid Intake After Hemodialysis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Thrice weekly maintenance hemodialysis
Willing and able to provide written informed consent
Disqualifiers
Diabetes Mellitus
Residual Urinary Volume > 500 ml/day
Being able to self-monitor one's body weight and blood pressure
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 1 trial groupGroup A: Hemodialysis Patients (nondiabetic)
Trial outcomes
Primary outcomes
1
T50%IDWG
Time to achieve ≥50% cumulative interdialytic weight gain (T50%IDWG) from the last hemodialysis treatment
Time frame
Up to one week2
Cumulative IDWG% curve
Shape of cumulative interdialytic weight gain curve (linear vs nonlinear)
Time frame
Up to one weekSecondary outcomes
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.
Time frame
One week, Interdialytic intervals2
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.
Time frame
One week, Interdialytic intervals3
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
Time frame
One week, Interdialytic intervals4
Daytime vs Nighttime cumulative IDWG%
Comparison between Daytime vs Nighttime cumulative interdialytic weight gain %
Time frame
One week, Interdialytic intervalsSponsors and contacts
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Source ClinicalTrials.gov