Role of Biomarkers in Patients Undergoing Dialysis Treatment

Study Overview
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Brief Summary
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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

Official Title
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A Pilot stuDy to Investigate the Role of Biomarkers and Bioimpedance technologY to Assess VolumE Status In Patients underGoing Hemodialysis Treatment

Conditions
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Volemia in Dialysis Patients

Intervention / Treatment
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* Device: bioelectrical impedance measurement and biomarker measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years old Patient on dialysis since > 1 month Voluntarily signed informed consent Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hemodialysis patients<br>A total of 30 patients - measuring volume status by bioelectrical impedance measurement as well as clinical evaluation and comparing with the novel biomarker | Device: bioelectrical impedance measurement and biomarker measurement<br>* Measuring volume status with bioelectrical impedance measurement and comparing with biomarker level<br>|
| Peritoneal dialysis patients<br>A total of 15 patients - measuring volume status by bioelectrical impedance measurement as well as clinical evaluation and comparing with the novel biomarker | Device: bioelectrical impedance measurement and biomarker measurement<br>* Measuring volume status with bioelectrical impedance measurement and comparing with biomarker level<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of sCD146 level with overhydration assessed by bioimpedance technology | For hemodialysis patients measurements will be concluded within 3 weeks, for peritoneal dialysis patients measures will be concluded within 3 months | 3 weeks to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of sCD146 level measured after dialysis and ultrafiltration rate | for hemodialysis patients measurements will be concluded within 3 weeks | 3 weeks | 
| Correlation of sCD146 level and clinical evaluation of volume status | For hemodialysis patients measurements will be concluded within 3 weeks, for peritoneal dialysis patients measures will be concluded within 3 months | 3 weeks to 3 months | 
| Correlation of sCD146 level and level of NT-proBNP | For hemodialysis patients measurements will be concluded within 3 weeks, for peritoneal dialysis patients measures will be concluded within 3 months | 3 weeks to 3 months | 
| Correlation of sCD146 level and mortality as assessed prospectively in 6 months follow-up |  | 6 months | 
| Correlation of sCD146 level and hospitalizations 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 | 
| Correlation of sCD146 level and shunt complications as assessed prospectively in 6 months follow-up |  | 6 months |