Clinical trial NCT02962635: Role of Biomarkers in Patients Undergoing Dialysis Treatment
Official title: A Pilot stuDy to Investigate the Role of Biomarkers and Bioimpedance technologY to Assess VolumE Status In Patients underGoing Hemodialysis Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Volemia in Dialysis Patients
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2016-11-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with end stage renal failure on hemodialysis and peritoneal dialysis

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


Eligibility criteria: 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)

Primary outcomes:
measure: Correlation of sCD146 level with overhydration assessed by bioimpedance technology
timeFrame: 3 weeks to 3 months
Secondary outcomes:
measure: Correlation of sCD146 level measured after dialysis and ultrafiltration rate
timeFrame: 3 weeks
measure: Correlation of sCD146 level and clinical evaluation of volume status
timeFrame: 3 weeks to 3 months
measure: Correlation of sCD146 level and level of NT-proBNP
timeFrame: 3 weeks to 3 months
measure: Correlation of sCD146 level and mortality as assessed prospectively in 6 months follow-up
timeFrame: 6 months
measure: Correlation of sCD146 level and hospitalizations as assessed prospectively in 6 months follow-up
timeFrame: 6 months
measure: Correlation of sCD146 level and cardiovascular complications as assessed prospectively in 6 months follow-up
timeFrame: 6 months
measure: Correlation of sCD146 level and shunt complications as assessed prospectively in 6 months follow-up
timeFrame: 6 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: University Hospital Zürich, Zürich, Switzerland
name: Stephan Segerer, MD
role: PRINCIPAL_INVESTIGATOR
References: