Volemia in Dialysis PatientsDRYWEIGHTNCT02962635
Role of Biomarkers in Patients Undergoing Dialysis Treatment
An observational study of Volemia in Dialysis Patients, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Volemia in Dialysis Patients
- What is being tested?
- bioelectrical impedance measurement and biomarker measurement
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2016to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with end stage renal failure on hemodialysis and peritoneal dialysis
Who may be able to join
- Age > 18 years old
- Patient on dialysis since > 1 month
- Voluntarily signed informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Volemia in Dialysis Patients
- Being tested
- bioelectrical impedance measurement and biomarker measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioelectrical impedance measurement and biomarker measurementDevice
Measuring volume status with bioelectrical impedance measurement and comparing with biomarker level
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: bioelectrical impedance measurement and biomarker measurement | |
| 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 Receives: Device: bioelectrical impedance measurement and biomarker measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 weeks to 3 months
Secondary outcomes (7)
Correlation of sCD146 level measured after dialysis and ultrafiltration rate
for hemodialysis patients measurements will be concluded within 3 weeks
Measured: 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
Measured: 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
Measured: 3 weeks to 3 months
Correlation of sCD146 level and mortality as assessed prospectively in 6 months follow-up
Measured: 6 months
Correlation of sCD146 level and hospitalizations as assessed prospectively in 6 months follow-up
Measured: 6 months
Correlation of sCD146 level and cardiovascular complications as assessed prospectively in 6 months follow-up
Measured: 6 months
Correlation of sCD146 level and shunt complications as assessed prospectively in 6 months follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volemia in Dialysis PatientsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Segerer, MD, Principal investigator, University Hospital Zürich, Zürich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962635
- Sponsor's protocol ID
- DRYWEIGHT
- Acronym
- DRYWEIGHT
- Status last verified
- Aug 2021
- First submitted
- 2 Nov 2016
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot stuDy to Investigate the Role of Biomarkers and Bioimpedance technologY to Assess VolumE Status In Patients underGoing Hemodialysis Treatment
- ClinicalTrials.gov ID
- NCT02962635
- Acronym / sponsor ID
- DRYWEIGHT / DRYWEIGHT
- Conditions
- Volemia in Dialysis Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Oct 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patients | – | Device: bioelectrical impedance measurement and biomarker measurementA total of 30 patients - measuring volume status by bioelectrical impedance measurement as well as clinical evaluation and comparing with the novel biomarker |
| Peritoneal dialysis patients | – | Device: bioelectrical impedance measurement and biomarker measurementA total of 15 patients - measuring volume status by bioelectrical impedance measurement as well as clinical evaluation and comparing with the novel biomarker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end stage renal failure on hemodialysis and peritoneal dialysis
Key inclusion criteria (3 listed)
- Age > 18 years old
- Patient on dialysis since > 1 month
- Voluntarily signed informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bioelectrical impedance measurement and biomarker measurementMeasuring volume status with bioelectrical impedance measurement and comparing with biomarker level | Device | Hemodialysis patients, Peritoneal dialysis patients |
Primary outcome
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
7 secondary outcomes
Correlation of sCD146 level measured after dialysis and ultrafiltration rate
Time frame: 3 weeks
Correlation of sCD146 level and clinical evaluation of volume status
Time frame: 3 weeks to 3 months
Correlation of sCD146 level and level of NT-proBNP
Time frame: 3 weeks to 3 months
Correlation of sCD146 level and mortality as assessed prospectively in 6 months follow-up
Time frame: 6 months
Correlation of sCD146 level and hospitalizations as assessed prospectively in 6 months follow-up
Time frame: 6 months
Correlation of sCD146 level and cardiovascular complications as assessed prospectively in 6 months follow-up
Time frame: 6 months
Correlation of sCD146 level and shunt complications as assessed prospectively in 6 months follow-up
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Segerer, MD principal investigator
University Hospital Zürich, Zürich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Volemia in Dialysis Patients, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of sCD146 level with overhydration assessed by bioimpedance technology (time frame: 3 weeks to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.