Clinical trial NCT01659333: The Association Between Arterial Stiffness and Assessment of Hydration State in Peritoneal Dialysis Patients
Official title: Volume Status in Peritoneal Dialysis Patients With Using Different Determining Methods.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorders Associated With Peritoneal Dialysis
Keywords: Peritoneal, Dialysis
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We evaluated 60 patients' hydration states were measured by bioimpedance spectroscopy methods. Patients were assigned to normo and hypervolemic groups according to Body composition monitor(BCM) results. Also, normalized calf resistivity (nRho) was calculated from resistance at 5 Khz 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. Additionally, all patients underwent conventional echocardiography and their left ventricular diastolic functions were evaluated. The patients were grouped using the BCM method because, according to the literature, this method is the only one that can classify subjects in terms of volume conditions.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Terminated of patients recruiting
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Nephrology Department
Study officials:
affiliation: TC Erciyes University
name: Murat Sipahioglu, MD
role: STUDY_DIRECTOR
References:
citation: Kocyigit I, Sipahioglu MH, Orscelik O, Unal A, Celik A, Abbas SR, Zhu F, Tokgoz B, Dogan A, Oymak O, Kotanko P, Levin NW. The association between arterial stiffness and fluid status in peritoneal dialysis patients. Perit Dial Int. 2014 Nov-Dec;34(7):781-90. doi: 10.3747/pdi.2013.00057. Epub 2014 Jan 2.