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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 October 2015
Main ID:  NCT02443376
Date of registration: 10/05/2015
Prospective Registration: No
Primary sponsor: Medical University of Warsaw
Public title: The Effects of Hemodialysis Session on Vascular Stiffness PWV/CP/HD
Scientific title: The Effects of Hemodialysis Session on Pulse Wave Velocity and Central Arterial Pressure
Date of first enrolment: May 2015
Target sample size: 90
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02443376
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Poland
Contacts
Name:     Janusz Wyzgal, Professor
Address: 
Telephone:
Email:
Affiliation:  Medical University of Warsaw, Department of Nephrologic Nursing
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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)

Exclusion Criteria:

- not meet the above criteria

- episode of illness (for example: infection)

- pregnancy



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Arteriopathic Disease
Aortic Stiffness
Arterial Calcification
Complication of Hemodialysis
Intervention(s)
Device: Complior Analyse System
Device: BCM- Body Composition Monitor
Primary Outcome(s)
Differences in carotid-femoral pulse wave velocity [m/s] just before and after hemodialysis session [Time Frame: 1 day]
Secondary Outcome(s)
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]
Differences in central aortic pressure [mmHg] just before and after hemodialysis session [Time Frame: 1 day]
Secondary ID(s)
PWV/CP/HD/2015/05
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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