The Association Between Arterial Stiffness and Assessment of Hydration State in Peritoneal Dialysis Patients

Disorders Associated With Peritoneal Dialysis Clinical Trial

Official title:

Volume Status in Peritoneal Dialysis Patients With Using Different Determining Methods.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01659333
• Other study ID #: 2010/10
• Status: Completed
• Phase: N/A
• First received: August 4, 2012
• Last updated: August 4, 2012
• Start date: January 2011
• Est. completion date: February 2012

Study information

• Verified date: August 2012
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Dry weight (DW) assessment is essential for the efficient treatment of peritoneal dialysis (PD) patients but so far objective methods for DW assessment have not been established for daily clinical practice. Our aim was to evaluate hydration state in PD patients by using a body composition monitor (BCM) and calf bioimpedance (c-BI) and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels and to compare both methods with arterial stiffness.

Description:

We evaluated 60 patients using a new BCM device that implies a validated body composition model. This method allows correct quantification of extracellular fluid overload or deficiency (normal limits:-1.1 to +1.1L). Patients were assigned to normo and hypervolemic groups according to BCM results. Also, normalized calf resistivity (nRho) was calculated from resistance at 5 Khz using c-BI and the levels of NT-proBNP were measured in all study patients. The analyses of arterial stiffness were performed by using the pulse wave velocity (PWV) technique on the patients. All patients underwent conventional echocardiography and their left ventricular diastolic functions were evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Peritoneal dialysis patients

• All participants over 18 years of age

Exclusion Criteria:

• Patients with valvular heart disease

• Patients with coronary artery disease

• Patients with cardiomyopathy

• Patients with ESRD who underwent hemodialysis

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Disorders Associated With Peritoneal Dialysis

Locations

Country	Name	City	State
Turkey	Erciyes University Nephrology Department	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Terminated of patients recruiting		One year	No

External Links

•   http://tip.erciyes.edu.tr/etikkurul_ana_sayfa.asp, more informaiton for our study in this link.