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OpenTrials
Completed

NCT Number: NCT00182338

Evaluation of Volume Status in Peritoneal Dialysis Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • St. Joseph's Healthcare Hamilton

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 16, 2005
Registry last updated
Jul 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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