Renal DialysisNCT03905122
Effects of Continuous Venous Dialysis and Hemodialysis on Fluid Dynamics by Bioreactance Method
An observational study of Renal Dialysis, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Dialysis methods applied at the bedside and dialysis methods applied in hemodialysis unit are widely applied in patients with renal insufficiency. Especially hemodynamically affected patients are less affected by hemodynamics as a result of using dialysis methods. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Renal Dialysis
- What is being tested?
- bioreactans tool
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2018to 15 Jun 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in need of dialysis treatment
Who may be able to join
- patients required dialysis therapy
Who cannot join
- under 18 years old
- confirmed or undiagnosed brain death
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Continuous Venous Dialysis and Hemodialysis on Fluid Dynamics by Bioreactance Method
Dialysis methods applied at the bedside and dialysis methods applied in hemodialysis unit are widely applied in patients with renal insufficiency. Especially hemodynamically affected patients are less affected by hemodynamics as a result of using dialysis methods. It is a completely non-invasive method by bioreactance method and it can be done to measure the intra-body fluid status with the help of the glued probes. The aim of this study is to investigate the effects of continuous venous dialysis and hemodialysis on the fluid dynamics applied at the bedside with bioreactance method. In this way, the patient can develop more comfortable hemodynamic changes. Patients in the Surgery, Reanimation and Postoperative Intensive Care Unit with more than 24 hours of hospitalization and bedside dialysis or hemodialysis will be included in the study. Before the dialysis, body fluid measurements will be made with bioreactance, and after dialysis in patients receiving hemodialysis, and in dialysis patients 6, 12, 24 and 36 hours.
Read the detailed description
Dialysis methods applied at the bedside and dialysis methods applied in hemodialysis unit are widely applied in patients with renal insufficiency. Especially hemodynamically affected patients are less affected by hemodynamics as a result of using dialysis methods. Dialysis in the hemodialysis unit is a method used in intensive care patients and is preferred especially in patients with stable hemodynamics. In dialysis methods, changes occur frequently in the body fluids of the patient. It is a completely non-invasive method by bioreactance method and it can be done to measure the intra-body fluid status with the help of the glued probes. The aim of this study is to investigate the effects of continuous venous dialysis and hemodialysis on the fluid dynamics applied at the bedside with bioreactance method. As a result of measurements with buioreactans method, fluid balance in patients will be understood more easily. In this way, the patient can develop more comfortable hemodynamic changes. Patients in the Surgery, Reanimation and Postoperative Intensive Care Unit with more than 24 hours of hospitalization and bedside dialysis or hemodialysis will be included in the study. Before the dialysis, body fluid measurements will be made with bioreactance, and after dialysis in patients receiving hemodialysis, and in dialysis patients 6, 12, 24 and 36 hours.
- Conditions
- Renal Dialysis
- Being tested
- bioreactans tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioreactans toolDevice
It is a completely non-invasive method by bioreactance method and it can be done to measure the intra-body fluid status with the help of the probes.
| Study group | Role | What they receive |
|---|---|---|
| continous veno-venous hemodialysis | to measure the fluid changes by using bioreactance method in continous veno-venous hemodialysis group Receives: Device: bioreactans tool | |
| hemodialysis | to measure the fluid changes by using bioreactance method in hemodialysis group Receives: Device: bioreactans tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in thoracic fluid content
change in thoracic fluid content
Measured: before and after hemodialysis therapy, before bedside continous venovenous dialysis therapy and 6,12,24 and 36. hours
change in Cardiac Output
change in Cardiac Output
Measured: before and after hemodialysis therapy, before bedside continous venovenous dialysis therapy and 6,12,24 and 36. hours
change in Cardiac Index
change in Cardiac Index
Measured: before and after hemodialysis therapy, before bedside continous venovenous dialysis therapy and 6,12,24 and 36. hours
change in stroke volum
change in stroke volum
Measured: before and after hemodialysis therapy, before bedside continous venovenous dialysis therapy and 6,12,24 and 36. hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start15 Jun 2018
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Mehmet Turan Inal, Trakya University
- Investigators
- Ahmet Senol Uyar, Specialist, Principal investigator, Trakya University, Edirne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905122
- Sponsor's protocol ID
- TUTF-BAEK 2018/229
- Status last verified
- Oct 2020
- First submitted
- 24 Dec 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Continuous Venous Dialysis and Hemodialysis on Fluid Dynamics by Bioreactance Method
- ClinicalTrials.gov ID
- NCT03905122
- Acronym / sponsor ID
- TUTF-BAEK 2018/229
- Conditions
- Renal Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 5 Apr 2019 (actual)
- 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.
Dialysis methods applied at the bedside and dialysis methods applied in hemodialysis unit are widely applied in patients with renal insufficiency. Especially hemodynamically affected patients are less affected by hemodynamics as a result of using dialysis methods. It is a completely non-invasive method by bioreactance method and it can be done to measure the intra-body fluid status with the help of the glued probes. The aim of this study is to investigate the effects of continuous venous dialysis and hemodialysis on the fluid dynamics applied at the bedside with bioreactance method. In this way, the patient can develop more comfortable hemodynamic changes. Patients in the Surgery, Reanimation and Postoperative Intensive Care Unit with more than 24 hours of hospitalization and bedside dialysis or hemodialysis will be included in the study. Before the dialysis, body fluid measurements will be made with bioreactance, and after dialysis in patients receiving hemodialysis, and in dialysis patients 6, 12, 24 and 36 hours.
Detailed description
Dialysis methods applied at the bedside and dialysis methods applied in hemodialysis unit are widely applied in patients with renal insufficiency. Especially hemodynamically affected patients are less affected by hemodynamics as a result of using dialysis methods. Dialysis in the hemodialysis unit is a method used in intensive care patients and is preferred especially in patients with stable hemodynamics. In dialysis methods, changes occur frequently in the body fluids of the patient. It is a completely non-invasive method by bioreactance method and it can be done to measure the intra-body fluid status with the help of the glued probes. The aim of this study is to investigate the effects of continuous venous dialysis and hemodialysis on the fluid dynamics applied at the bedside with bioreactance method. As a result of measurements with buioreactans method, fluid balance in patients will be understood more easily. In this way, the patient can develop more comfortable hemodynamic changes. Patients in the Surgery, Reanimation and Postoperative Intensive Care Unit with more than 24 hours of hospitalization and bedside dialysis or hemodialysis will be included in the study. Before the dialysis, body fluid measurements will be made with bioreactance, and after dialysis in patients receiving hemodialysis, and in dialysis patients 6, 12, 24 and 36 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continous veno-venous hemodialysis | – | Device: bioreactans toolto measure the fluid changes by using bioreactance method in continous veno-venous hemodialysis group |
| hemodialysis | – | Device: bioreactans toolto measure the fluid changes by using bioreactance method in hemodialysis group |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in need of dialysis treatment
Key inclusion criteria (1 listed)
- patients required dialysis therapy
Key exclusion criteria (2 listed)
- under 18 years old
- confirmed or undiagnosed brain death
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 |
|---|---|---|
| bioreactans toolIt is a completely non-invasive method by bioreactance method and it can be done to measure the intra-body fluid status with the help of the probes. | Device | continous veno-venous hemodialysis, hemodialysis |
Primary outcome
change in thoracic fluid content
Time frame: before and after hemodialysis therapy, before bedside continous venovenous dialysis therapy and 6,12,24 and 36. hours
change in thoracic fluid content
change in Cardiac Output
Time frame: before and after hemodialysis therapy, before bedside continous venovenous dialysis therapy and 6,12,24 and 36. hours
change in Cardiac Output
change in Cardiac Index
Time frame: before and after hemodialysis therapy, before bedside continous venovenous dialysis therapy and 6,12,24 and 36. hours
change in Cardiac Index
change in stroke volum
Time frame: before and after hemodialysis therapy, before bedside continous venovenous dialysis therapy and 6,12,24 and 36. hours
change in stroke volum
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 8 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Ahmet Senol Uyar, Specialist principal investigator
Trakya University, Edirne
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 Renal Dialysis, run by Trakya University at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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 8 Oct 2020. 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 Turkey (Türkiye). 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?
change in thoracic fluid content (time frame: before and after hemodialysis therapy, before bedside continous venovenous dialysis therapy and 6,12,24 and 36. hours). The study lists 4 primary outcomes in all. 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 8 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.