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Role of Biomarkers in Patients Undergoing Dialysis Treatment

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02962635
Acronym
DRYWEIGHT
Enrollment
45
Registered
2016-11-11
Start date
2016-10-31
Completion date
2019-01-31
Last updated
2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Volemia in Dialysis Patients

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

Interventions

DEVICEbioelectrical impedance measurement and biomarker measurement

Measuring volume status with bioelectrical impedance measurement and comparing with biomarker level

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University of Zurich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Correlation of sCD146 level with overhydration assessed by bioimpedance technology3 weeks to 3 monthsFor hemodialysis patients measurements will be concluded within 3 weeks, for peritoneal dialysis patients measures will be concluded within 3 months

Secondary

MeasureTime frameDescription
Correlation of sCD146 level and clinical evaluation of volume status3 weeks to 3 monthsFor 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 level of NT-proBNP3 weeks to 3 monthsFor 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-up6 months
Correlation of sCD146 level measured after dialysis and ultrafiltration rate3 weeksfor hemodialysis patients measurements will be concluded within 3 weeks
Correlation of sCD146 level and cardiovascular complications as assessed prospectively in 6 months follow-up6 months
Correlation of sCD146 level and shunt complications as assessed prospectively in 6 months follow-up6 months
Correlation of sCD146 level and hospitalizations as assessed prospectively in 6 months follow-up6 months

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026