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

NCT ID: NCT01659333

Last Updated: 2012-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Disorders Associated With Peritoneal Dialysis

Keywords

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Peritoneal, Dialysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Ismail Kocyigit

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murat Sipahioglu, MD

Role: STUDY_DIRECTOR

TC Erciyes University

Locations

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Erciyes University Nephrology Department

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 24385328 (View on PubMed)

Related Links

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http://tip.erciyes.edu.tr/

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

Other Identifiers

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2010/10

Identifier Type: -

Identifier Source: org_study_id