Relationship Between Blood Pressure and Pulse Wave Velocity Measurements in Peritoneal Dialysis

January 6, 2020 updated by: Vaios Vasileios, Aristotle University Of Thessaloniki

Longitudinal Change of Arterial Stiffness Indices in Relation to Ambulatory Aortic and Branchial Pressure in Long Term Peritoneal Dialysis Patients

This study evaluates the relationship between Ambulatory Aortic and Branchial blood pressure vs Office blood pressure measurements with the changes in arterial stiffness indices, in long-term Peritoneal Dialysis (PD) patients. These parameters will be monitored both cross-sectionally at the start of the study and prospectively over a 6 month period.

Study Overview

Status

Unknown

Conditions

Detailed Description

All participants will be monitored over a 6 month period during which 7 monthly visits will be performed. Brachial and aortic blood pressure (BP), wave reflection and arterial stiffness indices will be assessed with the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany). The above hemodynamic and arterial wall parameters will be measured for 24-hours on visits 1 (baseline) and 7 (month 6). The monitor will be set to obtain recordings 3 times/hour from 11:00 pm to 06:59 am and 2 times/hour from 07:00 am to 10:59 pm. Measurements will be used for the analysis if >80% of recordings were valid with no more than two non-consecutive day hours with fewer than two valid measurements, and no more than one night hour without valid recording, according to recommendations for ambulatory BP monitoring. Bioelectrical Impendance Analysis (BIA) with the Fresenius Body Composition Monitor (BCM - Fresenius Medical Care, Bad Homberg, Germany) will be performed on visits 1, 4 and 6 in order to assess the hydration status and body composition parameters of the participants.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

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

Study Contact

Study Locations

  • Greece
      • Thessaloniki, Greece, 54621
        • Recruiting
        • Ahepa University Hospital
        • Contact:
          • Vasileios Vaios, MD

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

40 patients with end stage renal disease receiving peritoneal dialysis for more than 3 months.

Description

Inclusion Criteria:

  1. Age 18 years old or higher
  2. Renal replacement therapy with Peritoneal Dialysis (Automated or Continuous Ambulatory) for at least 3 months prior to study enrollment
  3. Patient to have provided informed written consent

Exclusion Criteria:

  1. Ongoing atrial fibrillation
  2. Hospitalization for acute myocardial infarction, unstable angina or acute ischemic stroke within the 3 previous months
  3. Recent episode of PD-related peritonitis or exit site infection 1 month or less prior to study enrollment
  4. Bilateral functioning or non-functioning arteriovenous fistula (AVF) and/or arteriovenous graft (AVG) used earlier for dialysis access in patients previously treated with hemodialysis
  5. Body mass index (BMI) of >40 kg/m2
  6. History of malignancy or any other clinical condition associated with very poor prognosis

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour ambulatory Branchial vs office Branchial Systolic BP (SBP) as determinants of Pulse Wave Velocity
Time Frame: 6 months
24-hour ambulatory Branchial vs office Branchial SBP: which measurement correlates stronger with the changes in Pulse Wave Velocity over a 6 month period
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour ambulatory Aortic SBP vs 24-hour ambulatory Branchial SBP as determinants of Pulse Wave Velocity
Time Frame: 6 months
24-hour ambulatory Aortic SBP vs 24-hour ambulatory Branchial SBP: which measurement correlates stronger with the changes in Pulse Wave Velocity over a 6 month period
6 months
Short-term variability of 24-hour ambulatory Branchial and Aortic SBP as a determinant of Pulse Wave Velocity
Time Frame: 0, 6 months
Assessing the correlation between the short-term variability of 24-hour ambulatory Branchial and Aortic SBP with the changes in Pulse Wave Velocity at the start of the study and over a 6 month period
0, 6 months
Visit-to-visit variability of Branchial SBP as a determinant of Pulse Wave Velocity
Time Frame: 6 months
Assessing the predictive value of visit-to-visit variability of Branchial SBP for the changes in Pulse Wave Velocity over a 6 month period
6 months
Office blood pressure monitoring for the diagnosis of hypertension in peritoneal dialysis patients
Time Frame: 0, 6 months
Assessing whether or not office blood pressure measurements can diagnose hypertension or control of hypertension, based on the 24-hour ambulatory recordings
0, 6 months
The effect of overhydration on 24-hour ambulatory measurements
Time Frame: 0, 3, 6 months
The correlation between overhydration (defined by the measurement of fluid status using Bioelectrical Impendence Analysis) and the 24-hour ambulatory Aortic and Branchial SBP measurements at the start of the study and over a 6 month period
0, 3, 6 months

Collaborators and Investigators

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

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Study Director: Vassilios Liakopoulos, MD, PhD, Department of Medicine, Aristotle University of Thessaloniki

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 (ACTUAL)

July 18, 2018

Primary Completion (ANTICIPATED)

August 30, 2020

Study Completion (ANTICIPATED)

August 30, 2020

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

July 30, 2018

First Posted (ACTUAL)

July 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MedAuth

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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