Vascular Reactivity in Kidney Disease Patients

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Changing hemoglobin concentration

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring Diabetes, Hemoglobin, Dialysis, Vascular reactivity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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

Sites / Locations

The Royal Melbourne Hospital

Outcomes

Primary Outcome Measures

Change in pulse wave velocity at the three different haemoglobin levels

Secondary Outcome Measures

Full Information

NCT ID

NCT00226902

First Posted

September 26, 2005

Last Updated

May 4, 2015

Sponsor

Melbourne Health

1. Study Identification

Unique Protocol Identification Number

NCT00226902

Brief Title

Vascular Reactivity in Kidney Disease Patients

Official Title

Integrated Studies in Vascular Reactivity and Anaemia Correction Therapy in Endstage Kidney Disease Patients

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Melbourne Health

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Diabetes, Hemoglobin, Dialysis, Vascular reactivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Changing hemoglobin concentration

Primary Outcome Measure Information:

Title

Change in pulse wave velocity at the three different haemoglobin levels

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lawrence P McMahon, MD

Organizational Affiliation

Melbourne Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Royal Melbourne Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

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

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial