Vascular Reactivity in Kidney Disease Patients
Dialysis patients suffer from many problems with blood vessels and this is even more so for patients with the added complication of diabetes. Diabetics have a number of reasons for vascular disease and one of the new areas of research is looking at the cells that line the blood vessels, called endothelial cells. It is thought that the number of red blood cells in the blood (haemoglobin concentration) affects the function of these cells. There is very little information available on what haemoglobin level is best for dialysis patients. As diabetics account for almost 40% of dialysis patients worldwide it is important to understand the effect different haemoglobin levels will have on the blood vessels.
Hypothesis: Endothelial cell function and the related expansile capacity of blood vessels are affected by different haemoglobin concentrations [Hb] in dialysis patients.
Kidney Failure, Chronic
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Procedure: Changing hemoglobin concentration
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Integrated Studies in Vascular Reactivity and Anaemia Correction Therapy in Endstage Kidney Disease Patients|
- Change in pulse wave velocity at the three different haemoglobin levels
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
This project is going to ask dialysis patients (both diabetic and non-diabetic) to undergo a series of tests at three different time points over a one year period: a baseline set of tests, tested when haemoglobin is maintained at 130-140g/L and repeat the tests when haemoglobin is maintained at 105-115g/L. The current recommendation for haemoglobin is 110-120g/L. Patients will not be required to take any study medication but a specialist kidney doctor, using their usual medications of iron and erythropoietin therapy, will change their haemoglobin levels.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226902
|The Royal Melbourne Hospital|
|Melbourne, Victoria, Australia, 3050|
|Principal Investigator:||Lawrence P McMahon, MD||Melbourne Health|