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

NCT00852514 | Completed Phase 4 DMC

• 1 other identifier: VGHIRB 95-08-28A
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Fluid Overload; Heart Diseases

Keywords

Bioimpedance; ultrafiltration; blood pressure; pulse pressure

Outcome Measures

Primary Outcomes (1)

• systolic blood pressure

  one year

Study Arms (1)

Monthly BIA

EXPERIMENTAL

monthly BIA to monitor fluid status

Device: Bioelectrical impedance-guide dry weight reduction

Interventions

Bioelectrical impedance-guide dry weight reduction DEVICE

for optimal determination of fluid status, monthly BIA was performed to monitor fluid status and avoid dehydration

Monthly BIA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 to 80

You may not qualify if:

• type I DM
• Severe heart failure
• unstable angina

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Hypertension; Edema; Heart Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jinn-Yang Chen, MD, PhD

  Division of Nephrology, Taipei Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: February 27, 2009
• Study Start: September 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: February 27, 2009

Record last verified: 2009-02

Locations

TW (1)