Hemodynamics in Chronic Kidney Disease

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).

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Key information

Conditions

Chronic Kidney Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medicine and Life science

Hasselt, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

whole body fluid status

Time frame: Baseline, every 3 months during 1 year

The primary objective is to associate the bioimpedance-determined fluid status [fluid overload versus non-fluid overload] with kidney function decline in patients with chronic kidney disease stage 3 (59-30ml/min), 4 (29-15ml/min) and 5 (< 15 ml/min).

Secondary outcomes

identify the clinical factors associated with fluid overload during a longitudinal follow up

Time frame: Baseline, every 3 months during 1 year

Secondary outcomes of interest are the central volume status (measured as ejection fraction in % by echocardiography and thoracic bioimpedance in Ohms in combination with photoplethysmography), the cardiac systolic and diastolic function (measured by echocardiography), cardiovascular events, hospitalizations, inflammatory- and nutrition status (by whole body bioimpedance measurements), and quality of life (by Short Form 36 questionnaire).

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Registry information

Official study title

Improving the Hemodynamic Profile Of Chronic Renal Patients by Use of Bioimpedance

Acronym: HORUZ

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: May 23, 2025
Registry last updated: May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed