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

NCT ID: NCT03607747

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-18
• Study Completion Date: 2020-08-30

Brief Summary

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.

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.

Conditions

End Stage Renal Disease; Peritoneal Dialysis; Arterial Sclerosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

Vaios Vasileios

Principal Investigator, Division of Nephrology and Hypertension, 1st Department of Medicine, AHEPA University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vassilios Liakopoulos, MD, PhD

Role: STUDY_DIRECTOR

Department of Medicine, Aristotle University of Thessaloniki

Locations

AHEPA University Hospital

Thessaloniki, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Vasileios Vaios, MD

Role: CONTACT

vvaios_85@yahoo.gr

+306984568904

Facility Contacts

Vasileios Vaios, MD

Role: primary

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Identifier Type: -

Identifier Source: org_study_id