Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Feb 2021Dec 2026

First Submitted

Initial submission to the registry

January 13, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 25, 2021

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

5.8 years

First QC Date

January 13, 2021

Last Update Submit

April 28, 2026

Conditions

Keywords

HemodialysisInterdialytic Weight GainThirst

Outcome Measures

Primary Outcomes (2)

  • T50%IDWG

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

    Up to one week

  • Cumulative IDWG% curve

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

    Up to one week

Secondary Outcomes (4)

  • Correlations of T50%IDWG

    One week, Interdialytic intervals

  • Correlations of Nighttime cumulative %IDWG

    One week, Interdialytic intervals

  • Comparisons between IDWG% curves

    One week, Interdialytic intervals

  • Daytime vs Nighttime cumulative IDWG%

    One week, Interdialytic intervals

Study Arms (1)

Hemodialysis Patients (nondiabetic)

Nondiabetic adult hemodialysis patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Age ≥ 18 years
  • Thrice weekly maintenance hemodialysis
  • Willing and able to provide written informed consent

You may not qualify if:

  • Diabetes Mellitus
  • Residual Urinary Volume \> 500 ml/day
  • Being able to self-monitor one's body weight and blood pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Adam Linton Unit

London, Ontario, N6A 5W9, Canada

RECRUITING

Westmount Kidney Care Centre

London, Ontario, N6K 1M6, Canada

RECRUITING

Study Officials

  • Christopher W. McIntyre, MD, PhD

    London Health Sciences Centre, Western University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher W. McIntyre, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Director of The Lilibeth Caberto Kidney Clinical Research Unit

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 25, 2021

Study Start

February 25, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations