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Hemodynamics in Chronic Kidney Disease

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06987032
Acronym
HORUZ
Enrollment
71
Registered
2025-05-23
Start date
2021-01-09
Completion date
2022-03-09
Last updated
2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Failure

Brief summary

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

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.

Interventions

None listed

Sponsors

Ziekenhuis Oost-Limburg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
whole body fluid statusBaseline, every 3 months during 1 yearThe 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

MeasureTime frameDescription
identify the clinical factors associated with fluid overload during a longitudinal follow upBaseline, every 3 months during 1 yearSecondary 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).

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026