Pilot study to review alternative assessments of adequacy of dialysis in patients with kidney failure
| ISRCTN | ISRCTN70556765 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70556765 |
| Secondary identifying numbers | Protocol version 1.1 |
- Submission date
- 11/10/2013
- Registration date
- 01/11/2013
- Last edited
- 17/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
UCL Centre for Nephrology
Royal Free Hospital
London
NW3 2QG
United Kingdom
Study information
| Study design | Prospective cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Pilot study to review alternative assessments of adequacy of dialysis in patients with kidney failure: a prospective cohort study |
| Study objectives | 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(s) | NRES Committee London - Camden & Islington, September 2013, REC ref: 13/LO/0912, IRAS project ID: 129559 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2013 |
| Completion date | 31/10/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | More than 100 |
| Key inclusion criteria | 1. Treated for chronic kidney failure 2. Ability to provide informed consent |
| Key exclusion criteria | 1. Unable to provide informed consent 2. Aged below 18 years |
| Date of first enrolment | 01/10/2013 |
| Date of final enrolment | 31/10/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NW3 2QG
United Kingdom
Sponsor information
Hospital/treatment centre
Pond street
London
NW3 2QG
England
United Kingdom
"ROR" |
https://ror.org/01ge67z96 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/04/2015 | 17/12/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
17/12/2020: Publication reference added.
09/11/2017: No publications found, verifying study status with principal investigator.
