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Completed

NCT Number: NCT02962635

Role of Biomarkers in Patients Undergoing Dialysis Treatment

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

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Key information

Conditions

Volemia in Dialysis Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zürich

Zurich, 8901, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

bioelectrical impedance measurement and biomarker measurement

Device

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

Primary outcomes

  1. Correlation of sCD146 level with overhydration assessed by bioimpedance technology

    Time frame: 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 outcomes

  1. Correlation of sCD146 level measured after dialysis and ultrafiltration rate

    Time frame: 3 weeks

    for hemodialysis patients measurements will be concluded within 3 weeks

  2. Correlation of sCD146 level and clinical evaluation of volume status

    Time frame: 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

  3. Correlation of sCD146 level and level of NT-proBNP

    Time frame: 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

  4. Correlation of sCD146 level and mortality as assessed prospectively in 6 months follow-up

    Time frame: 6 months

  5. Correlation of sCD146 level and hospitalizations as assessed prospectively in 6 months follow-up

    Time frame: 6 months

  6. Correlation of sCD146 level and cardiovascular complications as assessed prospectively in 6 months follow-up

    Time frame: 6 months

  7. Correlation of sCD146 level and shunt complications as assessed prospectively in 6 months follow-up

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DRYWEIGHT

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 11, 2016
Registry last updated
Aug 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.