Role of Biomarkers in Patients Undergoing Dialysis Treatment
- Conditions
- Volemia in Dialysis Patients
- Interventions
- Device: bioelectrical impedance measurement and biomarker measurement
- Registration Number
- NCT02962635
- Lead Sponsor
- University of Zurich
- Brief Summary
A precise volume status assessment is critical to improve outcome of patients on dialysis. Yet, accurate assessment of fluid status remains a challenge. Currently, this is performed by clinical evaluation and regular weight measurements before and after dialysis, which is not always accurate. Moreover, bioimpedance technology is used in some centers for quantitative assessment of total body water. This approach has been validated for the assessment of volume status in dialysis patients, but requires the acquisition of specific tools and is time consuming. So far, no biomarker has been validated to quantify volume status in dialysis patients. Application of biomarkers might contribute to a better dialysis prescription and therefore to outcome improvement in dialysis. The investigators aim to investigate the role of a novel biomarkers (sCD146) to assess volume status in dialysis patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- Age > 18 years old
- Patient on dialysis since > 1 month
- Voluntarily signed informed consent
- Pregnant or breastfeeding women and women who plan to get pregnant during study
- Incapability of following the study protocol
- Acute illness
- Hospitalizations in the last week before inclusion
- Cardiac pacemakers or defibrillators
- Limb amputation or other factors precluding a reliable bioimpedance measurement (unreliable bioimpedance measurement)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Hemodialysis patients bioelectrical impedance measurement and biomarker measurement A total of 30 patients - measuring volume status by bioelectrical impedance measurement as well as clinical evaluation and comparing with the novel biomarker Peritoneal dialysis patients bioelectrical impedance measurement and biomarker measurement A total of 15 patients - measuring volume status by bioelectrical impedance measurement as well as clinical evaluation and comparing with the novel biomarker
- Primary Outcome Measures
Name Time Method Correlation of sCD146 level with overhydration assessed by bioimpedance technology 3 weeks to 3 months For hemodialysis patients measurements will be concluded within 3 weeks, for peritoneal dialysis patients measures will be concluded within 3 months
- Secondary Outcome Measures
Name Time Method Correlation of sCD146 level and clinical evaluation of volume status 3 weeks to 3 months For hemodialysis patients measurements will be concluded within 3 weeks, for peritoneal dialysis patients measures will be concluded within 3 months
Correlation of sCD146 level and hospitalizations as assessed prospectively in 6 months follow-up 6 months Correlation of sCD146 level and shunt complications as assessed prospectively in 6 months follow-up 6 months Correlation of sCD146 level measured after dialysis and ultrafiltration rate 3 weeks for hemodialysis patients measurements will be concluded within 3 weeks
Correlation of sCD146 level and level of NT-proBNP 3 weeks to 3 months For hemodialysis patients measurements will be concluded within 3 weeks, for peritoneal dialysis patients measures will be concluded within 3 months
Correlation of sCD146 level and mortality as assessed prospectively in 6 months follow-up 6 months Correlation of sCD146 level and cardiovascular complications as assessed prospectively in 6 months follow-up 6 months
Trial Locations
- Locations (1)
University Hospital Zürich
🇨🇭Zurich, Switzerland