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

NCT01659333 | Completed

• 1 other identifier: 2010/10
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorders Associated With Peritoneal Dialysis

Keywords

Peritoneal, Dialysis

Outcome Measures

Primary Outcomes (1)

• Terminated of patients recruiting

  One year

Study Arms (2)

Peritoneal dialysis, hypervolemia

All calculations are automatically performed by the software of the BCM device. Absolute over hydration (OH) is the difference between the expected patient's ECW under normal physiological conditions and the actual ECW, whereas the relative over hydration (Rel. OH) is defined as the OH to ECW ratio. Normohydration is defined when OH is between the 10th and the 90th percentile for healthy, age- and gender-matched individuals from the reference population, i.e., between 10th percentile (-1.1 L) to 90th percentile (+1.1 L), while volumes below and above this range define underhydration and overhydration, respectively.

Peritoneal dialysis, normovolemia

All calculations are automatically performed by the software of the BCM device. Absolute over hydration (OH) is the difference between the expected patient's ECW under normal physiological conditions and the actual ECW, whereas the relative over hydration (Rel. OH) is defined as the OH to ECW ratio. Normohydration is defined when OH is between the 10th and the 90th percentile for healthy, age- and gender-matched individuals from the reference population, i.e., between 10th percentile (-1.1 L) to 90th percentile (+1.1 L), while volumes below and above this range define underhydration and overhydration, respectively.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Peritoneal dialysis patients
• All participants over 18 years of age

You may not qualify if:

• Patients with valvular heart disease
• Patients with coronary artery disease
• Patients with cardiomyopathy
• Patients with ESRD who underwent hemodialysis

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Nephrology Department

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 24385328 DERIVED

Related Links

• http://tip.erciyes.edu.tr/etikkurul\_ana\_sayfa.asp, more informaiton for our study in this link.

Study Officials

• Murat Sipahioglu, MD

  TC Erciyes University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 4, 2012
• First Posted: August 7, 2012
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: August 7, 2012

Record last verified: 2012-08

Locations

TU (1)