The Optimization of Blood Pressure and Fluid Status Control With Eight-Polar Bioelectrical Impedance Analysis
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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 |
- 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 |
Inclusion Criteria:
- age 18 to 80
Exclusion Criteria:
- type I DM
- Severe heart failure
- unstable angina
Contacts and Locations| Taiwan | |
| Taipei Veterans General Hospital | |
| Taipei, Taiwan, 112 | |
| 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 Water Intoxication Cardiovascular Diseases Vascular Diseases |
Water-Electrolyte Imbalance Metabolic Diseases Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 19, 2013