We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00852514
Recruitment Status : Completed
First Posted : February 27, 2009
Last Update Posted : February 27, 2009
Sponsor:
Information provided by:
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.

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

Study Type : Interventional  (Clinical Trial)
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 : September 2006
Primary Completion Date : September 2007
Study Completion Date : September 2007

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



Primary Outcome Measures :
  1. systolic blood pressure [ Time Frame: one year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 to 80

Exclusion Criteria:

  • type I DM
  • Severe heart failure
  • unstable angina

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jinn-Yang Chen, Taipei Veterans General Hospital
ClinicalTrials.gov Identifier: NCT00852514     History of Changes
Other Study ID Numbers: VGHIRB 95-08-28A
First Posted: February 27, 2009    Key Record Dates
Last Update Posted: February 27, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases