Condition category
Urological and Genital Diseases
Date applied
11/10/2013
Date assigned
01/11/2013
Last edited
01/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
andrewdavenport@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Davenport

ORCID ID

Contact details

UCL Centre for Nephrology
Royal Free Hospital
London
NW32QG
United Kingdom

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. We hypothesise that newer targets for treating kidney dialysis patients are required to improve survival.

Ethics approval

NRES Committee London - Camden & Islington; September 2013; REC reference: 13/LO/0912; IRAS project ID:129559

Study design

Prospective cohort study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below 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 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

01/10/2013

Overall trial end date

31/10/2015

Reason abandoned

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

UCL Centre for Nephrology
London
NW32QG
United Kingdom

Sponsor information

Organisation

Royal Free Hospital (UK)

Sponsor details

Pond street
London
NW3 2QG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes