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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852514
• Other study ID #: VGHIRB 95-08-28A
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2009
• Last updated: February 26, 2009
• Start date: September 2006
• Est. completion date: September 2007

Study information

• Verified date: February 2009
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age 18 to 80

Exclusion Criteria:

• type I DM

• Severe heart failure

• unstable angina

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fluid Overload
• Heart Diseases
• Hypertension

Intervention

Device:
• Bioelectrical impedance-guide dry weight reduction
for optimal determination of fluid status, monthly BIA was performed to monitor fluid status and avoid dehydration

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systolic blood pressure		one year	No