Role of Biomarkers in Patients Undergoing Dialysis Treatment

NCT ID: NCT02962635

Last Updated: 2021-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-01-31

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

Detailed Description

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Conditions

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Volemia in Dialysis Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hemodialysis patients

A total of 30 patients

\- measuring volume status by bioelectrical impedance measurement as well as clinical evaluation and comparing with the novel biomarker

bioelectrical impedance measurement and biomarker measurement

Intervention Type DEVICE

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

Peritoneal dialysis patients

A total of 15 patients

\- measuring volume status by bioelectrical impedance measurement as well as clinical evaluation and comparing with the novel biomarker

bioelectrical impedance measurement and biomarker measurement

Intervention Type DEVICE

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

Interventions

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bioelectrical impedance measurement and biomarker measurement

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

Intervention Type DEVICE

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephan Segerer, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zürich, Zürich, Switzerland

Locations

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University Hospital Zürich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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DRYWEIGHT

Identifier Type: -

Identifier Source: org_study_id

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