Evaluation of Volume Status in Peritoneal Dialysis Patients

NCT ID: NCT00182338

Last Updated: 2011-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases Inflammation Peritoneal Dialysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Peritoneal Dialysis Patients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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McMaster University

Principal Investigators

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Scott K Brimble, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Peter Margetts, MD, PhD

Role: STUDY_DIRECTOR

McMaster University

David N Churchill, MD, MSc

Role: STUDY_DIRECTOR

McMaster University

Azim S Gangji, MD

Role: STUDY_DIRECTOR

McMaster University

Locations

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St. Joseph's Healthcare

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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Gangji AS, Brimble KS, Margetts PJ. Association between markers of inflammation, fibrosis and hypervolemia in peritoneal dialysis patients. Blood Purif. 2009;28(4):354-8. doi: 10.1159/000232937. Epub 2009 Sep 1.

Reference Type RESULT
PMID: 19729905 (View on PubMed)

Gangji AS, Helal BA, Churchill DN, Brimble KS, Margetts PJ. Association between N-terminal propeptide B-type natriuretic peptide and markers of hypervolemia. Perit Dial Int. 2008 May-Jun;28(3):308-11. No abstract available.

Reference Type RESULT
PMID: 18474925 (View on PubMed)

Other Identifiers

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PD 04-2305

Identifier Type: -

Identifier Source: org_study_id

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