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Cohort Study Comparing Short Daily Hemodialysis (HD) With Conventional HD

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by McMaster University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00182156
First Posted: September 16, 2005
Last Update Posted: June 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by:
McMaster University
  Purpose
This study is examining the effects of short daily hemodialysis on platelet function, fluid volume control, arterial stiffness and patient quality of life, as compared to conventional hemodialysis.

Condition
End-Stage Renal Disease Thrombocytopathy Cardiovascular Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cohort Study Examining the Effects of Short Daily Hemodialysis As Compared to Conventional Hemodialysis in Outpatients Treated at St Joseph's Healthcare, Hamilton

Resource links provided by NLM:


Further study details as provided by McMaster University:

Estimated Enrollment: 40
Study Start Date: October 2004
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
conventional HD
2
short daily HD
3
PD

Detailed Description:
Bleeding is a common cause of morbidity and mortality in patients with end stage renal disease. A major cause of uremic bleeding is due to platelet dysfunction. It has been theorized that in renal failure, toxins accumulate, some of which inhibit primary hemostasis. All aspects of normal platelet function are affected. Platelet function has previously been difficult to quantify but recently a novel test, the platelet function analyzer (PFA-100) has been determined to be both sensitive and specific in assessing platelet function. Conventional hemodialysis (CHD) has been shown to partially correct thrombocytopathy. Enhanced uremic clearance can now be attained through the use of short daily hemodialysis (SDHD). Cardiovascular disease is the most common cause of mortality in dialysis patients, accounting for 40% of deaths. Volume overload is associated with high blood pressure, left ventricular hypertrophy and elevated markers of inflammation and these factors have been associated with increased cardiovascular mortality. SDHD has been shown to control blood pressure and limit volume expansion. Pulse wave velocity (PWV) has been used to assess arterial compliance and reduction of arterial elasticity of large and small arteries which have been associated with cardiovascular outcomes.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Short daily HD v PD v conventional HD
Criteria

Inclusion Criteria:

  • Patient is enrolled in short daily hemodialysis program
  • Patient is minimum of 18 years old

Exclusion Criteria:

  • Patient is unable to consent due to language barrier
  • Patient is unable to consent due to cognitive difficulties
  • Patient refuses consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182156


Locations
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Hamilton Health Sciences Corporation
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Azim Gangji, MD Clinical Scholar, Medicine
Principal Investigator: Catherine M Clase, MD Associate Professor, Medicine
  More Information

Responsible Party: Dr Azim Gangji, McMaster University
ClinicalTrials.gov Identifier: NCT00182156     History of Changes
Other Study ID Numbers: Nephrology Divisional Funds
First Submitted: September 10, 2005
First Posted: September 16, 2005
Last Update Posted: June 17, 2008
Last Verified: June 2008

Keywords provided by McMaster University:
hemodialysis
platelet function analyzer
bioimpedance
pulse wave velocity
end stage renal disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Kidney Failure, Chronic
Blood Platelet Disorders
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Hematologic Diseases