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

• Conditions: End Stage Renal Disease; Arterial Sclerosis; Peritoneal Dialysis

• Registration Number: NCT03607747
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Study Timeline

• Study Start: 2018-07-18
• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-07-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07
• Primary Completion: 2020-08-30
• Study Completion: 2020-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24-hour ambulatory Branchial vs office Branchial Systolic BP (SBP) as determinants of Pulse Wave Velocity	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

Secondary Outcome Measures

Name	Time	Method
24-hour ambulatory Aortic SBP vs 24-hour ambulatory Branchial SBP as determinants of Pulse Wave Velocity	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
Office blood pressure monitoring for the diagnosis of hypertension in peritoneal dialysis patients	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
Short-term variability of 24-hour ambulatory Branchial and Aortic SBP as a determinant of Pulse Wave Velocity	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
The effect of overhydration on 24-hour ambulatory measurements	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
Visit-to-visit variability of Branchial SBP as a determinant of Pulse Wave Velocity	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

Trial Locations

Locations (1)

AHEPA University Hospital; 🇬🇷 Thessaloniki, Greece