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

• Sponsor: Taipei Veterans General Hospital, Taiwan (Other)
• Overall Status: Completed
• CT.gov ID: NCT00852514
• Collaborator: (none)
• Enrollment: 132
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 11

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Fluid Overload; Heart Diseases	Device: Bioelectrical impedance-guide dry weight reduction	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Optimization of Blood Pressure and Fluid Status Control With Eight-Polar Bioelectrical Impedance Analysis
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Sep 1, 2007
• Actual Study Completion Date: Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Monthly BIA monthly BIA to monitor fluid status	Device: Bioelectrical impedance-guide dry weight reduction; for optimal determination of fluid status, monthly BIA was performed to monitor fluid status and avoid dehydration

Outcome Measures

Primary Outcome Measures

1. systolic blood pressure [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age 18 to 80

Exclusion Criteria:

• type I DM

• Severe heart failure

• unstable angina

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veterans General Hospital	Taipei		Taiwan	112

Sponsors and Collaborators

• Taipei Veterans General Hospital, Taiwan

Investigators

• Principal Investigator: Jinn-Yang Chen, MD, PhD, Division of Nephrology, Taipei Veterans General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00852514
• Other Study ID Numbers: VGHIRB 95-08-28A
• First Posted: Feb 27, 2009
• Last Update Posted: Feb 27, 2009
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: Bioimpedance; ultrafiltration; blood pressure; pulse pressure
• Additional relevant MeSH terms: Heart Diseases

Study Results

No Results Posted as of Feb 27, 2009