Plain English Summary
Background and study aims
The dose or adequacy of dialysis treatments (removal of waste from the body) for kidney failure patients is currently assessed by the removal of urea, a waste product of protein turnover. However, simply changing dialysis treatments to increase the amount of urea removed has not been shown to increase patient survival. Cardiac disease is the most common cause of death in kidney failure patients, and additional risk factors for cardiac death have been reported for these patients. Newer treatment methods that can reduce these risk factors are necessary. In this study we wish to measure three key risk factors associated with increased risk of death in different groups of kidney failure patients. We also aim to find out whether any of the current treatments for kidney failure reduce these risk factors. Information from this initial study would then hopefully be used for future research.
Who can participate?
Patients with long-term kidney disease who are treated by outpatient dialysis can participate in the study.
What does the study involve ?
We plan to measure skin auto fluorescence using a non-invasive technique that shines a light onto the forearm skin and measures the reflection. This can be done when patients are sitting or lying down whilst having dialysis. In addition to the usual tests that are done during their routine medical care we would wish to take 10 ml of blood when the patients are having their routine blood testing. If patients have not had a recent electrical recording of the heart (ECG) as part of their normal routine care (performed annually) we will record an ECG and look at the variability in heart beats. We assess the relationship between these risk factors and heart disease. We also measure blood pressure using a standard blood pressure cuff placed on the arm, and use this blood pressure recording to find out the stiffness of the arteries and also measure the thickness of the artery at the wrist or foot using ultrasound. This is a non-invasive technique and can be performed as the patient has their dialysis treatment.
What are the possible benefits and risks of participating?
There may be no immediate benefits to any patient. However, if any of the tests performed show significant risk factors for heart disease, these will be made available to your supervising kidney consultant who may then make changes to your treatment. Apart from an additional blood test, all other tests are non-invasive and painless and can be performed whilst patients are having dialysis.
Where is the study run from?
The study is run from the Centre for Nephrology at the Royal Free Hospital, UK.
When is study starting and how long is it expected to run for?
It is due to start in January 2013 and depending upon recruitment, is expected to end in Oct 2015.
Who is funding the study?
The study is funded by the Royal Free Hospital, UK.
Who is the main contact?
Dr Andrew Davenport
protocol version 1.1
Pilot study to review alternative assessments of adequacy of dialysis in patients with kidney failure: a prospective cohort study
Currently the amount of dialysis treatment given to patients with chronic kidney disease is based on the amount of urea removed during a dialysis session. Using this guideline for dosing dialysis, in the UK the 5-year survival of kidney dialysis patients is marginally better than that for ovarian cancer, and worse than that of bowel cancer. We hypothesise that newer targets for treating kidney dialysis patients are required to improve survival.
NRES Committee London - Camden & Islington; September 2013; REC reference: 13/LO/0912; IRAS project ID:129559
Prospective cohort study
Primary study design
Secondary study design
Non randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Renal and Cardiac
Conventional markers of dialysis adequacy and in addition measurement of skin autofluorescence, plasma endotoxin and modified albumin.
Cardiovascular assessments: blood pressure (pulse wave velocity), ECG (with analysis for autonomic dysfunction), and measurement of diameter of radial or dorsalis pedis artery.
Primary outcome measures
To determine the practicability of measuring skin autofluorescence, endotoxin and modified albumin in the study population and whether these factors correlate with conventional markers of dialysis adequacy.
Blood samples will be taken at entry into the study and then at 12 months to determine concentrations of endotoxin and modified albumin. Similarly blood pressure, ECG and skin autofluorescence will be measured at study entry and then at 12 months. Measurements of arterial size will be made once at study entry.
Secondary outcome measures
To determine whether skin autofluorescence, endotoxin and modified albumin correlate with cardiovascular risk factors
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Treated for chronic kidney failure
2. Ability to provide informed consent
Target number of participants
More than 100
Participant exclusion criteria
1. Unable to provide informed consent
2. Aged below 18 years
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
UCL Centre for Nephrology
Royal Free Hospital (UK)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting