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Evaluation of Volume Status in Peritoneal Dialysis Patients
This study has been completed.
First Received: September 13, 2005   Last Updated: May 27, 2008   History of Changes
Sponsored by: Hamilton Health Sciences
Information provided by: McMaster University
ClinicalTrials.gov Identifier: NCT00182338
  Purpose

Patients with kidney failure on dialysis have a much higher risk of developing cardiovascular disease as compared to the general population. Recently, two large studies have shown that increasing the amount of dialysis does not decrease cardiovascular disease. It is known that retaining too much fluid leads to high blood pressure and thickening of the heart wall. Peritoneal dialysis is a method of home dialysis which allows dialysis patients autonomy and independence. This study will measure blood levels of a protein called N-BNP and measure the extent of body fluid by a machine called a bioimpedance analyzer. This device administers an undetectible electric current which distributes throughout total body water. The relationship between these tests and the clinical presence of volume expansion will be assessed. In addition, the extent of total body fluid and it's impact on heart attacks, heart failure and stroke will be determined.


Condition
Cardiovascular Diseases
Inflammation
Peritoneal Dialysis

MedlinePlus related topics: Heart Failure Kidney Failure
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Evaluation of Volume Status in Peritoneal Dialysis Patients

Further study details as provided by McMaster University:

Study Start Date: January 2005
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Patients with end-stage renal disease (ESRD) have a higher risk than the general population of developing premature cardiovascular disease; the reasons for this are complex. Two recent randomized controlled trials in peritoneal dialysis patients have demonstrated that targeting patients to higher dialysis clearance values is not associated with a reduction in mortality. It is known that patients on peritoneal dialysis are more likely to be volume expanded, develop left ventricular hypertrophy, and have inadequate blood pressure relative to patients on hemodialysis. As a result there has been increased attention on the role of fluid management in reducing the risk of developing congestive heart failure and other adverse cardiovascular events in peritoneal dialysis patients. Extracellular fluid volume and total body water can be accurately assessed with multi-frequency bioimpedance analysis (BIA). Estimation of volume expansion by measuring the natriuretic peptide N-BNP produced by cardiac tissue in response to ventricular wall stretch can also be used.

The purpose of this study is to determine whether volume status, as measured by BIA and N-BNP levels, correlates with clinical volume assessment, cardiovascular outcomes, peritoneal membrane transport properties and markers of inflammation such as serum albumin and C-reactive protein.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients,
  • 18 years of age or older,
  • with end stage renal disease on peritoneal dialysis for a minimum of 3 months

Exclusion Criteria:

  • Peritonitis in previous 3 months;
  • history of bilateral lower limb amputation;
  • inability to provide informed consent;
  • presence of a pacemaker or defibrillator;
  • anticipated death or transplant within 6 months of recruitment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182338

Locations
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Hamilton Health Sciences
Investigators
Principal Investigator: Scott K Brimble, MD McMaster University
Study Director: Peter Margetts, MD, PhD McMaster University
Study Director: David N Churchill, MD, MSc McMaster University
Study Director: Azim S Gangji, MD McMaster University
  More Information

No publications provided

Study ID Numbers: PD 04-2305
Study First Received: September 13, 2005
Last Updated: May 27, 2008
ClinicalTrials.gov Identifier: NCT00182338     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
cardiovascular outcomes
congestive heart failure
Peritoneal Membrane transport properties
Arterial stiffening
Inflammatory markers

Study placed in the following topic categories:
Heart Failure
Inflammation

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases
Inflammation

ClinicalTrials.gov processed this record on May 07, 2009