Clinical Trials Directory

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UnknownNCT03607747

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

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

Status
Unknown
Phase
Study type
Observational
Enrollment
40 (estimated)
Sponsor
Aristotle University Of Thessaloniki · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2018-07-18
Primary completion
2020-08-30
Completion
2020-08-30
First posted
2018-07-31
Last updated
2020-01-07

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT03607747. Inclusion in this directory is not an endorsement.