NCT06987032CompletedNot Applicable
Improving the Hemodynamic Profile Of Chronic Renal Patients by Use of Bioimpedance
Ziekenhuis Oost-Limburg1 site in 1 country71 target enrollmentStarted: January 9, 2021Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- whole body fluid status
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
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(Baseline, every 3 months during 1 year)
Investigators
Study Sites (1)
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