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Evaluation of Volume Status in Peritoneal Dialysis Patients

This study has been completed.
Sponsor:
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182338
First received: September 13, 2005
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Volume Status in Peritoneal Dialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McMaster University:

Enrollment: 22
Study Start Date: January 2005
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Peritoneal Dialysis Patients

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
Sampling Method:   Non-Probability Sample
Study Population

Peritoneal dialysis clinic

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
McMaster University
St. Joseph's Healthcare Hamilton
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

Publications:

Responsible Party: Scott Brimble, McMaster University
ClinicalTrials.gov Identifier: NCT00182338     History of Changes
Other Study ID Numbers: PD 04-2305
Study First Received: September 13, 2005
Last Updated: July 19, 2011
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013