Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226902
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2005-09-26
Brief Title:
Vascular Reactivity in Kidney Disease Patients
Sponsor:
Melbourne Health
Organization:
Melbourne Health
Study Overview
Official Title:
Integrated Studies in Vascular Reactivity and Anaemia Correction Therapy in Endstage Kidney Disease Patients
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Hypothesis Endothelial cell function and the related expansile capacity of blood vessels are affected by different haemoglobin concentrations Hb in dialysis patients
Detailed Description:
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 130-140gL and repeat the tests when haemoglobin is maintained at 105-115gL The current recommendation for haemoglobin is 110-120gL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None