Hemodynamics in Chronic Kidney Disease

NCT06987032 | Completed

• 1 other identifier: ctu2019039
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Kidney Failure

Outcome Measures

Primary Outcomes (1)

• whole body fluid status

  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).

  Baseline, every 3 months during 1 year

Secondary Outcomes (1)

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

  Baseline, every 3 months during 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

206 patients with CKD stages 3-5 will be included from the outpatient clinic of Ziekenhuis Zuid-Oost Limburg in Genk (Belgium). A healthy control group for the cross-sectional part will be recruited through visitors and/or personnel of Ziekenhuis Oost-Limburg in Genk (Belgium).

You may qualify if:

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

You may not qualify if:

• 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.
• Pregnancy

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead

Study Sites (1)

Medicine and Life science

Hasselt, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and urine

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Pieter Vandervoort, PhD

  University Hasselt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: May 23, 2025
• Study Start: January 9, 2021
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2022
• Last Updated: May 23, 2025

Record last verified: 2021-01

Locations

BE (1)