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

Phase 4

Completed

• Conditions: Fluid Overload; Heart Diseases; Hypertension
• Interventions: Device: Bioelectrical impedance-guide dry weight reduction

• Registration Number: NCT00852514
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2009-02
• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-26
• Last Update Submitted: 2009-02-26
• Study First Posted: 2009-02-27
• Last Update Posted: 2009-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• age 18 to 80

Exclusion Criteria

• type I DM
• Severe heart failure
• unstable angina

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monthly BIA	Bioelectrical impedance-guide dry weight reduction	monthly BIA to monitor fluid status

Primary Outcome Measures

Name	Time	Method
systolic blood pressure	one year

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan