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

September 30, 2015 updated by: Łukasz Czyżewski, Medical University of Warsaw

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Mazovian
      • Warsaw, Mazovian, Poland, 02-091
        • Medical University of Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 80 consecutive patients on maintenance hemodialysis and 30 healthy subjects were included in this study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy subjects
Medical staff: medical doctors, nurses
Device: Complior Analyse System
Pulse Wave Velocity PWV and central Pressure analysis
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in carotid-femoral pulse wave velocity [m/s] just before and after hemodialysis session
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Differences in central aortic pressure [mmHg] just before and after hemodialysis session
Time Frame: 1 day
1 day
Differences in central aortic pressure [mmHg] and cuff blood pressure [mmHg] just before and after hemodialysis session
Time Frame: 1 day
1 day
Impact of fluid and nutritional status on carotid-femoral pulse wave velocity and central aortic pressure
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

May 10, 2015

First Submitted That Met QC Criteria

May 10, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Estimate)

October 2, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PWV/CP/HD/2015/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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