Status:
COMPLETED
Vascular Reactivity in Kidney Disease Patients
Lead Sponsor:
Melbourne Health
Conditions:
Kidney Failure, Chronic
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-80 years
Phase:
NA
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 an...
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...
Eligibility Criteria
Inclusion
- Aged 18-80 years
- Patients receiving either conventional haemodialysis 3-4 x week, for a duration of \> 6 months or peritoneal dialysis for a duration \>6 months
- Stable dialysis access for at least 3 months (Permcath / PTFE / AVF)
- On erythropoietin and iron therapy, with stable \[Hb\] x 2 months (105 - 135g/L)
Exclusion
- Uncontrolled BP: requiring dry weight or medication changes within 4 weeks prior to study
- Patients with dysrhythmias
- Pre dialysis SBP\> 180 mmHg on \> 2 times within a 2 week period
- Between dialysis weight gain \> 5% of body weight (if evident \> 2 times/ 2 week period)
- Soft tissue ulcers
- Non traumatic amputations
- 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
- Planned operative procedures within 6 months of study start (including Transplant, CABG, PTCA, vascular surgery)
- Dementia
- Clinical inability to comply with testing
- Malignancy (active / under treatment)
- Known hypo-responsiveness to ERT (\>200U/kg/wk)
- Evidence of chronic gastrointestinal bleeding
- Inadequate dialysis (PRU \< 65% or KT/V \< 1.2)
- Participation in investigational study within last 3 months
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
September 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00226902
Start Date
September 1 2006
End Date
September 1 2013
Last Update
May 5 2015
Active Locations (1)
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1
The Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050