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

Primary Purpose

Hypertension, Fluid Overload, Heart Diseases

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Bioelectrical impedance-guide dry weight reduction
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Bioimpedance, ultrafiltration, blood pressure, pulse pressure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18 to 80

Exclusion Criteria:

  • type I DM
  • Severe heart failure
  • unstable angina

Sites / Locations

  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Monthly BIA

Arm Description

monthly BIA to monitor fluid status

Outcomes

Primary Outcome Measures

systolic blood pressure

Secondary Outcome Measures

Full Information

First Posted
February 26, 2009
Last Updated
February 26, 2009
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT00852514
Brief Title
The Optimization of Blood Pressure and Fluid Status Control With Eight-Polar Bioelectrical Impedance Analysis
Official Title
The Optimization of Blood Pressure and Fluid Status Control With Eight-Polar Bioelectrical Impedance Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Fluid Overload, Heart Diseases
Keywords
Bioimpedance, ultrafiltration, blood pressure, pulse pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monthly BIA
Arm Type
Experimental
Arm Description
monthly BIA to monitor fluid status
Intervention Type
Device
Intervention Name(s)
Bioelectrical impedance-guide dry weight reduction
Intervention Description
for optimal determination of fluid status, monthly BIA was performed to monitor fluid status and avoid dehydration
Primary Outcome Measure Information:
Title
systolic blood pressure
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 to 80 Exclusion Criteria: type I DM Severe heart failure unstable angina
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinn-Yang Chen, MD, PhD
Organizational Affiliation
Division of Nephrology, Taipei Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

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

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