Role of Biomarkers in Patients Undergoing Dialysis Treatment (DRYWEIGHT)

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

Study Overview

• Status: Completed
• Conditions: Volemia in Dialysis Patients
• Intervention / Treatment: Device: bioelectrical impedance measurement and biomarker measurement

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8901
    • University Hospital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with end stage renal failure on hemodialysis and peritoneal dialysis

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: bioelectrical impedance measurement and biomarker measurement; 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	Device: bioelectrical impedance measurement and biomarker measurement; Measuring volume status with bioelectrical impedance measurement and comparing with biomarker level

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Stephan Segerer, MD, University Hospital Zurich, Zurich, Switzerland

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: November 2, 2016
• First Submitted That Met QC Criteria: November 10, 2016
• First Posted (Estimate): November 11, 2016

Study Record Updates

• Last Update Posted (Actual): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: DRYWEIGHT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED