Vascular Reactivity in Kidney Disease Patients

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.

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Key information

Conditions

Kidney Failure, Chronic Autoimmune Diseases Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Immune System Diseases Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Changing hemoglobin concentration

Procedure

Primary outcomes

Change in pulse wave velocity at the three different haemoglobin levels

Sponsors and collaborators

Lead sponsor

Melbourne Health

Other

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2013
Study completion: 2013
First posted: Sep 27, 2005
Registry last updated: May 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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