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The Optimization of Blood Pressure and Fluid Status Control With Eight-Polar Bioelectrical Impedance Analysis

NCT ID: NCT00852514

Last Updated: 2009-02-27

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

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-09-30

Brief Summary

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Peritoneal dialysis (PD) is a widely used modality of renal replacement therapy. Due to its continuous nature of therapy, better control of fluid status and preservation of residual renal function were presumed by most nephrologists. However, recent evidences showed that it might not be the case. The severity of fluid overloading and the need for anti-hypertensive agents to control blood pressure seems to be more severe for PD patients. Therefore, more aggressive strategy to control dry weight is mandatory in PD patients. However, over reduction of dry weight might affect residual renal function (RRF) and, probably, the survival of PD patients. A balance between reduction of dry weight and preservation of RRF is crucial for the care of PD patients. Currently, only clinical measures like cardiothoracic ratio on chest X-ray and absence of pedal edema were used to evaluate PD patient's dry weight. There is no objective method to determine dry weight accurately. In this prospective and randomized study, the investigators will use multi-frequency bio-impedance (MF-BIA) to detect intracellular and extracellular water (ECW) content of patients.

Detailed Description

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Conditions

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Hypertension Fluid Overload Heart Diseases

Keywords

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Bioimpedance ultrafiltration blood pressure pulse pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monthly BIA

monthly BIA to monitor fluid status

Group Type EXPERIMENTAL

Bioelectrical impedance-guide dry weight reduction

Intervention Type DEVICE

for optimal determination of fluid status, monthly BIA was performed to monitor fluid status and avoid dehydration

Interventions

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Bioelectrical impedance-guide dry weight reduction

for optimal determination of fluid status, monthly BIA was performed to monitor fluid status and avoid dehydration

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age 18 to 80

Exclusion Criteria

* type I DM
* Severe heart failure
* unstable angina
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Taipei Veterans General Hospital

Principal Investigators

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Jinn-Yang Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology, Taipei Veterans General Hospital

Locations

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Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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VGHIRB 95-08-28A

Identifier Type: -

Identifier Source: org_study_id