The Effects of Hemodialysis Session on Vascular Stiffness

Completed

• Conditions: Complication of Hemodialysis; Arteriopathic Disease; Aortic Stiffness; Arterial Calcification
• Interventions: Device: Complior Analyse System; Device: BCM- Body Composition Monitor

• Registration Number: NCT02443376
• Lead Sponsor: Medical University of Warsaw

Brief Summary

Central blood pressure and pulse wave velocity were measured using a Complior Analyse device before and immediately after the end of the dialysis session.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-10
• Study First Submitted QC: 2015-05-10
• Study First Posted: 2015-05-13
• Primary Completion: 2015-07
• Status Verified: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemodialysis patients	BCM- Body Composition Monitor	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
Hemodialysis patients	Complior Analyse System	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
Healthy subjects	Complior Analyse System	Medical staff: medical doctors, nurses

Primary Outcome Measures

Name	Time	Method
Differences in carotid-femoral pulse wave velocity [m/s] just before and after hemodialysis session	1 day

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Warsaw; 🇵🇱 Warsaw, Mazovian, Poland