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. The main aim of this study is to measure three key risk factors associated with increased risk of death in different groups of kidney failure patients. Another aim is 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
What does the study involve ?
Skin auto fluorescence is measured 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 10 ml of blood is taken 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) an ECG is recorded to look at the variability in heart beats. The relationship between these risk factors and heart disease is assessed. Blood pressure is also measured using a standard blood pressure cuff placed on the arm, and the recording is used 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 their supervising kidney consultant who may then make changes to their 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?
Royal Free Hospital (UK)
When is study starting and how long is it expected to run for?
October 2013 to October 2015
Who is funding the study?
Royal Free Hospital (UK)
Who is the main contact?
Dr Andrew Davenport
andrewdavenport@nhs.net
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol version 1.1
Study information
Scientific title
Pilot study to review alternative assessments of adequacy of dialysis in patients with kidney failure: a prospective cohort study
Acronym
Study hypothesis
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. The trialists hypothesise that newer targets for treating kidney dialysis patients are required to improve survival.
Ethics approval
NRES Committee London - Camden & Islington, September 2013, REC ref: 13/LO/0912, IRAS project ID: 129559
Study design
Prospective cohort study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Renal and cardiac
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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
01/10/2013
Overall trial end date
31/10/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Treated for chronic kidney failure
2. Ability to provide informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
More than 100
Participant exclusion criteria
1. Unable to provide informed consent
2. Aged below 18 years
Recruitment start date
01/10/2013
Recruitment end date
31/10/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Free Hospital
London
NW3 2QG
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Free Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list