Vascular Reactivity in Kidney Disease Patients

NCT ID: NCT00226902

Last Updated: 2015-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2013-09-30

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.

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 130-140g/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.

Conditions

Kidney Failure, Chronic; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Changing hemoglobin concentration

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Melbourne Health

OTHER

Sponsor Role: lead

Principal Investigators

Lawrence P McMahon, MD

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

Locations

The Royal Melbourne Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

Interactedd

Identifier Type: -

Identifier Source: org_study_id