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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00226902
Other study ID # Interactedd
Secondary ID
Status Completed
Phase N/A
First received September 26, 2005
Last updated May 4, 2015
Start date September 2006
Est. completion date September 2013

Study information

Verified date May 2015
Source Melbourne Health
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Interventional

Clinical Trial 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.


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 130-140g/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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date September 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Aged 18-80 years

2. Patients receiving either conventional haemodialysis 3-4 x week, for a duration of > 6 months or peritoneal dialysis for a duration >6 months

3. Stable dialysis access for at least 3 months (Permcath / PTFE / AVF)

4. On erythropoietin and iron therapy, with stable [Hb] x 2 months (105 - 135g/L)

Exclusion Criteria:

1. Uncontrolled BP: requiring dry weight or medication changes within 4 weeks prior to study

2. Patients with dysrhythmias

3. Pre dialysis SBP> 180 mmHg on > 2 times within a 2 week period

4. Between dialysis weight gain > 5% of body weight (if evident > 2 times/ 2 week period)

5. Soft tissue ulcers

6. Non traumatic amputations

7. Unstable cardiac function: ischaemic or non ischaemic events requiring modification of therapy, or admission to hospital within 3 months of study start: according to clinical discretion

8. Planned operative procedures within 6 months of study start (including Transplant, CABG, PTCA, vascular surgery)

9. Dementia

10. Clinical inability to comply with testing

11. Malignancy (active / under treatment)

12. Known hypo-responsiveness to ERT (>200U/kg/wk)

13. Evidence of chronic gastrointestinal bleeding

14. Inadequate dialysis (PRU < 65% or KT/V < 1.2)

15. Participation in investigational study within last 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Changing hemoglobin concentration


Locations

Country Name City State
Australia The Royal Melbourne Hospital Melbourne Victoria

Sponsors (1)

Lead Sponsor Collaborator
Melbourne Health

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in pulse wave velocity at the three different haemoglobin levels
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