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

This study has been completed.
Sponsor:
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT00852514
First received: February 26, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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 Intervention Phase
Hypertension
Fluid Overload
Heart Diseases
Device: Bioelectrical impedance-guide dry weight reduction
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Optimization of Blood Pressure and Fluid Status Control With Eight-Polar Bioelectrical Impedance Analysis

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • systolic blood pressure [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 132
Study Start Date: September 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 to 80

Exclusion Criteria:

  • type I DM
  • Severe heart failure
  • unstable angina
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00852514

Locations
Taiwan
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
  More Information

No publications provided

Responsible Party: Jinn-Yang Chen, Taipei Veterans General Hospital
ClinicalTrials.gov Identifier: NCT00852514     History of Changes
Other Study ID Numbers: VGHIRB 95-08-28A
Study First Received: February 26, 2009
Last Updated: February 26, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Bioimpedance
ultrafiltration
blood pressure
pulse pressure

Additional relevant MeSH terms:
Heart Diseases
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014