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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 10, 2005 | ||||||||
| Last Updated Date | June 16, 2008 | ||||||||
| Start Date ICMJE | October 2004 | ||||||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00182156 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Cohort Study Comparing Short Daily Hemodialysis (HD) With Conventional HD | ||||||||
| Official Title ICMJE | Cohort Study Examining the Effects of Short Daily Hemodialysis As Compared to Conventional Hemodialysis in Outpatients Treated at St Joseph's Healthcare, Hamilton | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Cohort, Cross-Sectional | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | December 2008 | ||||||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00182156 | ||||||||
| Responsible Party | Dr Azim Gangji, McMaster University | ||||||||
| Study ID Numbers ICMJE | Nephrology Divisional Funds | ||||||||
| Study Sponsor ICMJE | Hamilton Health Sciences | ||||||||
| Collaborators ICMJE | Nephrology Divisional Research Funds, St. Joseph's Healthcare | ||||||||
| Investigators ICMJE |
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| Information Provided By | McMaster University | ||||||||
| Verification Date | June 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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