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Target Weight Correction and Vascular Stiffness in Hemodialysis Patients

NCT03929471 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-02-28

No results posted yet for this study

Summary

Title of the study: Target weight correction and vascular stiffness in hemodialysis patients Study design: Randomized clinical trial in the study centre at two locations

Applied medical device:

1. Body Composition Monitor' (BCM, Fresenius) to measure fluid volume overload.
2. Arteriograph 24 (Tensiomed, Budapest, Hungry) to assess vascular stiffness before, during and after the intervention.

Study hypothesis: A protocolized adjustment of target weight guided by bio-impedance spectroscopy will improve fluid status, systolic and diastolic blood pressure, and reduce the arterial wall stiffness without increasing the prevalence of intradialytic hypotension.

Aim of the study:

1. To demonstrate improvement in fluid status by a target weight correction protocol which applies BCM measurements.
2. To demonstrate that better fluid volume control is associated with a) improvement in vascular health as assessed by pulse wave velocity and augmentation index and b) reduction in antihypertensive medications use.
3. To show that this approach does not lead to more episodes with intradialytic hypotension.

The number of patients: 70 patients

Conditions

  • Fluid Overload
  • Vascular Stiffness

Interventions

OTHER

Target weight correction protocol

The intervention group will undergo target weight correction process based on time averaged fluid overload measurement (by bio-impedance).

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Branko Braam, MD PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-06-01
Completion
2020-07-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03929471 on ClinicalTrials.gov