Arteriopathic DiseasePWV/CP/HDNCT02443376
The Effects of Hemodialysis Session on Vascular Stiffness
An observational study of Arteriopathic Disease and Arterial Calcification, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Central blood pressure and pulse wave velocity were measured using a Complior Analyse device before and immediately after the end of the dialysis session. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arteriopathic Disease, Arterial Calcification, Complication of Hemodialysis
- What is being tested?
- Complior Analyse System and BCM- Body Composition Monitor
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- May 2015to Sep 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 80 consecutive patients on maintenance hemodialysis and 30 healthy subjects were included in this study.
Who may be able to join
- give voluntary consent to participate in the study
- patients on maintenance hemodialysis at least 3 months
- stable dry weight
- single-pool Kt/V >1.4
- no clinical cardiovascular disease during the 6 months preceding entry
- medical staff (medical doctors, nurses)
Who cannot join
- not meet the above criteria
- episode of illness (for example: infection)
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Hemodialysis Session on Pulse Wave Velocity and Central Arterial Pressure
Central blood pressure and pulse wave velocity were measured using a Complior Analyse device before and immediately after the end of the dialysis session.
- Conditions
- Arteriopathic Disease, Arterial Calcification, Complication of Hemodialysis, Aortic Stiffness
- Being tested
- Complior Analyse System, BCM- Body Composition Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complior Analyse SystemDevice
Pulse Wave Velocity PWV and central Pressure analysis
BCM- Body Composition MonitorDevice
BCM - Body Composition Monitor gives information about:
Overhydration Urea distribution volume (V) Total body water, extracellular and intracellular water Lean Tissue Index (LTI) Fat Tissue Index (FTI) Body Cell Mass (BCM)
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis patients | Stable end-stage renal disease patients on maintenance conventional hemodialysis received 4-5 hours of treatment thrice weekly. Pulse wave velocity and central aortic pressure was measured before and after the midweek dialysis session.Overhydration Urea distribution volume (V) Total body water, extracellular and intracellular water Lean Tissue Index (LTI) Fat Tissue Index (FTI) Body Cell Mass (BCM) was measured before the midweek dialysis session just after Complior device Receives: Device: Complior Analyse System; Device: BCM- Body Composition Monitor | |
| Healthy subjects | Medical staff: medical doctors, nurses Receives: Device: Complior Analyse System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in carotid-femoral pulse wave velocity [m/s] just before and after hemodialysis session
Measured: 1 day
Secondary outcomes (3)
Differences in central aortic pressure [mmHg] just before and after hemodialysis session
Measured: 1 day
Differences in central aortic pressure [mmHg] and cuff blood pressure [mmHg] just before and after hemodialysis session
Measured: 1 day
Impact of fluid and nutritional status on carotid-femoral pulse wave velocity and central aortic pressure
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Arteriopathic DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łukasz Czyżewski, Medical University of Warsaw
- Investigators
- Janusz Wyzgał, Professor, Study chair, Medical University of Warsaw, Department of Nephrologic Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443376
- Sponsor's protocol ID
- PWV/CP/HD/2015/05
- Acronym
- PWV/CP/HD
- Status last verified
- Sep 2015
- First submitted
- 10 May 2015
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Assessment of health-related quality of life of patients after kidney transplantation in comparison with hemodialysis and peritoneal dialysis. Ann Transplant. 2014 Nov 9;19:576-85. doi: 10.12659/AOT.891265.
PubMed 25382249Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Comparative analysis of hypertension and its causes among renal replacement therapy patients. Ann Transplant. 2014 Nov 3;19:556-68. doi: 10.12659/AOT.891248.
PubMed 25365639Czyzewski L, Wyzgal J, Kolek A. Evaluation of selected risk factors of cardiovascular diseases among patients after kidney transplantation, with particular focus on the role of 24-hour automatic blood pressure measurement in the diagnosis of hypertension: an introductory report. Ann Transplant. 2014 Apr 28;19:188-98. doi: 10.12659/AOT.890189.
PubMed 24770703
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hemodialysis Session on Pulse Wave Velocity and Central Arterial Pressure
- ClinicalTrials.gov ID
- NCT02443376
- Acronym / sponsor ID
- PWV/CP/HD / PWV/CP/HD/2015/05
- Conditions
- Arteriopathic Disease, Arterial Calcification, Complication of Hemodialysis, Aortic Stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 May 2015 (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.
Central blood pressure and pulse wave velocity were measured using a Complior Analyse device before and immediately after the end of the dialysis session.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patients | – | Device: Complior Analyse System, Device: BCM- Body Composition MonitorStable end-stage renal disease patients on maintenance conventional hemodialysis received 4-5 hours of treatment thrice weekly. Pulse wave velocity and central aortic pressure was measured before and after the midweek dialysis session.Overhydration Urea distribution volume (V) Total body water, extracellular and intracellular water Lean Tissue Index (LTI) Fat Tissue Index (FTI) Body Cell Mass (BCM) was measured before the midweek dialysis session just after Complior device |
| Healthy subjects | – | Device: Complior Analyse SystemMedical staff: medical doctors, nurses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 80 consecutive patients on maintenance hemodialysis and 30 healthy subjects were included in this study.
Key inclusion criteria (6 listed)
- give voluntary consent to participate in the study
- patients on maintenance hemodialysis at least 3 months
- stable dry weight
- single-pool Kt/V >1.4
- no clinical cardiovascular disease during the 6 months preceding entry
Key exclusion criteria (3 listed)
- not meet the above criteria
- episode of illness (for example: infection)
- pregnancy
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 |
|---|---|---|
| Complior Analyse SystemPulse Wave Velocity PWV and central Pressure analysis | Device | Healthy subjects, Hemodialysis patients |
| BCM- Body Composition MonitorBCM - Body Composition Monitor gives information about: Overhydration Urea distribution volume (V) Total body water, extracellular and intracellular water Lean Tissue Index (LTI) Fat Tissue Index (FTI) Body Cell Mass (BCM) | Device | Hemodialysis patients |
Primary outcome
Differences in carotid-femoral pulse wave velocity [m/s] just before and after hemodialysis session
Time frame: 1 day
3 secondary outcomes
Differences in central aortic pressure [mmHg] just before and after hemodialysis session
Time frame: 1 day
Differences in central aortic pressure [mmHg] and cuff blood pressure [mmHg] just before and after hemodialysis session
Time frame: 1 day
Impact of fluid and nutritional status on carotid-femoral pulse wave velocity and central aortic pressure
Time frame: 1 day
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 2 Oct 2015.
- Background: PubMed 25382249Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Assessment of health-related quality of life of patients after kidney transplantation in comparison with hemodialysis and peritoneal dialysis. Ann Transplant. 2014 Nov 9;19:576-85. doi: 10.12659/AOT.891265.
- Results publication: PubMed 25365639Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Comparative analysis of hypertension and its causes among renal replacement therapy patients. Ann Transplant. 2014 Nov 3;19:556-68. doi: 10.12659/AOT.891248.
- Results publication: PubMed 24770703Czyzewski L, Wyzgal J, Kolek A. Evaluation of selected risk factors of cardiovascular diseases among patients after kidney transplantation, with particular focus on the role of 24-hour automatic blood pressure measurement in the diagnosis of hypertension: an introductory report. Ann Transplant. 2014 Apr 28;19:188-98. doi: 10.12659/AOT.890189.
Related trials for Arteriopathic Disease
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
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.
Janusz Wyzgał, Professor study chair
Medical University of Warsaw, Department of Nephrologic Nursing
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 Arteriopathic Disease and Arterial Calcification, run by Medical University of Warsaw at 1 site in Poland.
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 6 inclusion and 3 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 2 Oct 2015. 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 Poland. 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?
Differences in carotid-femoral pulse wave velocity [m/s] just before and after hemodialysis session (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02443376, which also lists 3 linked publications.
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 2 Oct 2015.