Interactive Studies of Endstage Diabetic Dialysis Patients
|ClinicalTrials.gov Identifier: NCT00175734|
Recruitment Status : Unknown
Verified January 2013 by University of British Columbia.
Recruitment status was: Active, not recruiting
First Posted : September 15, 2005
Last Update Posted : February 1, 2013
The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.
Hypothesis: The expansile capacity of blood vessels is affected by different hemoglobin concentrations in diabetic hemodialysis patients.
|Condition or disease||Intervention/treatment|
|Diabetes||Procedure: High Hemoglobin Concentration Procedure: Low Hemoglobin Concentration|
Vascular disease is an important cause of morbidity and mortality in patients with chronic kidney disease (CKD), of which a large proportion is diabetic. Diabetics have complex and multiple reasons for vascular disease, and there is accumulating evidence of associated poor endothelial cell function, particularly in those with kidney disease. One important mechanism through which this might occur relates to changes in shear rate and stress resulting from different viscosity levels. Such fluctuations are increasingly recognized to affect endothelial cell function and hence vessel-wall adaptability in both the short and long term.
Little is known of the consequence of different shear effects on endothelial cell function at various hemoglobin levels in kidney disease. There is some evidence to suggest however that, in the presence of micro-vascular disease, a relative anemia, with associated lower viscosity and shear stress, may be of benefit compared to higher hemoglobin levels.
Diabetics account for almost 40% of dialysis patients worldwide, and are the fastest growing component of the epidemic of CKD. Thus, an understanding of optimal treatment targets for anemia therapy, and the impact of different target levels of hemoglobin on vascular wall function is imperative.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Integrated Studies in Vascular Reactivity and Anemia Correction Therapy in Endstage Kidney Disease Patients|
|Study Start Date :||August 2005|
|Primary Completion Date :||December 2007|
|Estimated Study Completion Date :||December 2013|
Procedure: High Hemoglobin Concentration
- To determine what hemoglobin level is best for diabetic dialysis patients. Specific parameters: endothelial cell function and related expansile capacity of blood vessels. *Assessed through labs and pulse wave velocity test [ Time Frame: 8-12 months per participant ]
- Pulse rate, BP, respiratory rate, peripheral oxygen saturation, ECG during 6-min walk-test and Health Related Quality of Life Assessment as measured by questionnaires [ Time Frame: 8-12 months per participant ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175734
|Canada, British Columbia|
|St. Paul's Hospital|
|Vancouver, British Columbia, Canada|
|Principal Investigator:||Adeera Levin||University of British Columbia|