Hemodynamics in Chronic Kidney Disease

NCT ID: NCT06987032

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-09

Study Completion Date

2022-03-09

Brief Summary

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The goal of this observational study is to learn about the role of thoracic and whole body bioimpedance in the hemodynamic profile of patients with chronic kidney disease.

The main question it aims to answer is:

\- Is bioimpedance-determined fluid status associated with kidney function decline in patients with chronic kidney disease stage 3 - 5 (non dialysis).

Detailed Description

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Participants will be measured during their regular visit to their treating nephrologist.

During a follow up of one year, 3 or 4 visits will be scheduled.

* Bioimpedance and blood pressure measurements will be achieved by non-invasive techniques.
* Blood sampling will as much as possible coincide with regular blood samplings for clinical purposes.
* All subjects will undergo echocardiography at baseline and after one year follow up.

Conditions

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Chronic Kidney Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Prevalent non-dialysis patients with estimated glomerular filtration rate \< 60 ml/min (for chronic kidney disease subjects)
* Age \> 18 years
* Signed informed consent

Exclusion Criteria

* Acute kidney injury
* estimated glomerular filtration rate \< 20ml/min directly post-nephrectomy
* Clinical conditions affecting bioimpedance measurements: limb amputation, impaired skin integrity, brain stimulator, pacemaker with low threshold or unipolar pacemaker.
* Clinical conditions affecting body composition: liver cirrhosis, active infectious disease or any acute cardiovascular event (defined as cerebrovascular event, myocard infarction, heart failure) during the 3 months before screening for inclusion
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ziekenhuis Oost-Limburg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pieter Vandervoort, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hasselt

Locations

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Medicine and Life science

Hasselt, , Belgium

Site Status

Countries

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Belgium

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ctu2019039

Identifier Type: -

Identifier Source: org_study_id

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