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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ismail Kocyigit, TC Erciyes University
ClinicalTrials.gov Identifier:
NCT01659333
First received: August 4, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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.


Condition
Disorders Associated With Peritoneal Dialysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Volume Status in Peritoneal Dialysis Patients With Using Different Determining Methods.

Resource links provided by NLM:


Further study details as provided by TC Erciyes University:

Primary Outcome Measures:
  • Terminated of patients recruiting [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659333

Locations
Turkey
Erciyes University Nephrology Department
Kayseri, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
Investigators
Study Director: Murat Sipahioglu, MD Erciyes University
  More Information

Additional Information:
No publications provided

Responsible Party: Ismail Kocyigit, Associate Professor, TC Erciyes University
ClinicalTrials.gov Identifier: NCT01659333     History of Changes
Other Study ID Numbers: 2010/10
Study First Received: August 4, 2012
Last Updated: August 4, 2012
Health Authority: Turkey: Ethics Committee

Keywords provided by TC Erciyes University:
Peritoneal, Dialysis

ClinicalTrials.gov processed this record on July 26, 2014