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PWV/CP/HD: The Effects of Hemodialysis Session on Vascular Stiffness

Sponsor
Medical University of Warsaw (Other)
Overall Status
Completed
CT.gov ID
NCT02443376
Collaborator
(none)
90
Enrollment
1
Location
4
Duration (Months)
22.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Complior Analyse System
  • Device: BCM- Body Composition Monitor

Study Design

Study Type:
Observational
Actual Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effects of Hemodialysis Session on Pulse Wave Velocity and Central Arterial Pressure
Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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

Device: Complior Analyse System
Pulse Wave Velocity PWV and central Pressure analysis

Device: BCM- Body Composition Monitor
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)
Healthy subjects

Medical staff: medical doctors, nurses

Device: Complior Analyse System
Pulse Wave Velocity PWV and central Pressure analysis

Outcome Measures

Primary Outcome Measures

  1. Differences in carotid-femoral pulse wave velocity [m/s] just before and after hemodialysis session [1 day]

Secondary Outcome Measures

  1. Differences in central aortic pressure [mmHg] just before and after hemodialysis session [1 day]

  2. Differences in central aortic pressure [mmHg] and cuff blood pressure [mmHg] just before and after hemodialysis session [1 day]

  3. Impact of fluid and nutritional status on carotid-femoral pulse wave velocity and central aortic pressure [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Warsaw Warsaw Mazovian Poland 02-091

Sponsors and Collaborators

  • Medical University of Warsaw

Investigators

  • Study Chair: Janusz Wyzgał, Professor, Medical University of Warsaw, Department of Nephrologic Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Łukasz Czyżewski, Lukasz Czyzewski, Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT02443376
Other Study ID Numbers:
  • PWV/CP/HD/2015/05
First Posted:
May 13, 2015
Last Update Posted:
Oct 2, 2015
Last Verified:
Sep 1, 2015
Additional relevant MeSH terms:
Calcinosis

Study Results

No Results Posted as of Oct 2, 2015