The Effects of Hemodialysis Session on Vascular Stiffness

Complication of Hemodialysis Clinical Trial

— PWV/CP/HD  

Official title:

The Effects of Hemodialysis Session on Pulse Wave Velocity and Central Arterial Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443376
• Other study ID #: PWV/CP/HD/2015/05
• Status: Completed
• Phase: N/A
• First received: May 10, 2015
• Last updated: September 30, 2015
• Start date: May 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Stiffness
• Arterial Calcification
• Arteriopathic Disease
• Calcinosis
• Complication of Hemodialysis
• Vascular Calcification

Intervention

Device:
• Complior Analyse System
Pulse Wave Velocity PWV and central Pressure analysis
• BCM- Body Composition Monitor
BCM - Body Composition Monitor gives information about: Overhydration Urea distribution volume (V) Total body water, extracellular and intracellular water Lean Tissue Index (LTI) Fat Tissue Index (FTI) Body Cell Mass (BCM)

Locations

Country	Name	City	State
Poland	Medical University of Warsaw	Warsaw	Mazovian

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (3)

Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Assessment of health-related quality of life of patients after kidney transplantation in comparison with hemodialysis and peritoneal dialysis. Ann Transplant. 2014 Nov 9;19:576-85. doi: 10.12659/AOT.891265. — View Citation

Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Comparative analysis of hypertension and its causes among renal replacement therapy patients. Ann Transplant. 2014 Nov 3;19:556-68. doi: 10.12659/AOT.891248. — View Citation

Czyzewski L, Wyzgal J, Kolek A. Evaluation of selected risk factors of cardiovascular diseases among patients after kidney transplantation, with particular focus on the role of 24-hour automatic blood pressure measurement in the diagnosis of hypertension: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in carotid-femoral pulse wave velocity [m/s] just before and after hemodialysis session		1 day	No
Secondary	Differences in central aortic pressure [mmHg] just before and after hemodialysis session		1 day	No
Secondary	Differences in central aortic pressure [mmHg] and cuff blood pressure [mmHg] just before and after hemodialysis session		1 day	No
Secondary	Impact of fluid and nutritional status on carotid-femoral pulse wave velocity and central aortic pressure		1 day	No