Condition category
Urological and Genital Diseases
Date applied
03/05/2013
Date assigned
03/05/2013
Last edited
15/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Haemodialysis (HD) removes poisons from a patient's bloodstream when their kidneys no longer work. The best way of getting access to blood is through a permanent fistula, formed by surgically connecting a patient's artery and vein. Poor access is a major cause of ill health in HD patients so a well-functioning fistula is very important. Over the course of a few weeks, a newly formed fistula should strengthen enough to be able to be used for dialysis. Unfortunately, this does not always occur and this can cause problems with providing high-quality dialysis treatment. In addition, further operations may be required and there is the risk that dialysis treatment will need to be given through a dialysis catheter (a plastic tube that is inserted into one of the veins in the neck). These catheters carry a higher risk of infection. Anything that improves the chances that a fistula will be strong enough for dialysis is therefore important. A treatment called Far Infra Red (FIR) therapy has been shown to preserve the health of fistulas in patients already using them for HD. FIR therapy lamps emit a non-visible light and have a long history of use in different medical conditions and for sports injuries. FIR therapy seems to work by improving the function of blood vessels. The purpose of this study is to test whether FIR therapy might help strengthen newly-formed fistulas.

Who can participate?
The study is open to patients waiting to have a fistula formed and who are either already receiving dialysis or who have not yet started dialysis (i.e. they are ‘pre-dialysis’). They should be at least 18 years old, they should not have a reduced conscious level at the time of their first FIR therapy and should not have reduced peripheral sensation.

What does the study involve?
Participants in the study will be randomly allocated to either continue usual care (the control group) or to receive FIR therapy, using a FIR lamp, five times a week, at home for 6 weeks after surgery. Pre-dialysis patients will conduct all their treatments at home. Similarly, patients waiting to transfer from peritoneal dialysis to haemodialysis will conduct all their treatments at home. Patients already receiving haemodialysis will have treatment provided when they are on the dialysis machine. The remaining FIR treatments will, however, need to be performed at home, in between dialysis sessions. The development of fistulas in the two groups will be compared using ultrasound scanning, 6 and 12 weeks after surgery.

What are the possible benefits and risks of participating?
Improving the development of fistulas would be very desirable because of the problems HD patients suffer with poor fistulas. It is not yet clear whether FIR therapy will, in fact, improve the development of fistulas, which is why this study is being conducted. Provided the FIR lamp is used at the correct distance from the patient's arm, all that they should feel will be a sensation of warmth. This should not be uncomfortable but if it does become so, they should stop treatment - skin damage is very unlikely if this is done. As an extra precaution, we will ask the participant to examine their skin over their fistula after each FIR lamp treatment for ‘redness’. If this occurs, we will ask that they let us know and we will advise them to stop further treatment whilst this is being evaluated. FIR therapy requires the participant's co-operation in keeping their arm under the lamp for 40 minutes and also in removing it, if it ever becomes uncomfortable. Patients will not receive FIR therapy if they are unable to co-operate with treatment – for instance, if they lose consciousness or the ability to make decisions for themselves. FIR therapy is widely used across dialysis units in Taiwan without any reports of harm to patients. FIR lamps are also in widespread use in gyms and spas around the world.

Where is the study run from?
The study will be run from Renal Services centre at the Freeman Hospital, Newcastle upon Tyne, UK.

When is the study starting and how long is it expected to run for?
The study will run from 1st July 2013 to 31st October 2017.

Who is funding the study?
The study has been funded by Stanningley Pharma (UK) and by the Northern Counties Kidney Research Fund (UK).

Who is the main contact?
Dr N.S. Kanagasundaram
suren.kanagasundaram@nuth.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr N S Kanagasundaram

ORCID ID

Contact details

Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
suren.kanagasundaram@nuth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14042

Study information

Scientific title

Frequent, far infra-red (FIR) therapy for newly formed arterio-venous fistulas in dialysis and pre-dialysis patients

Acronym

Study hypothesis

Current hypothesis as of 15/09/2014:
Haemodialysis (HD) removes poisons from a patient's bloodstream when their kidneys no longer work. The best way of getting 'access' to blood is through a permanent fistula, formed by surgically connecting a patient's artery and vein.

Poor 'access' is a major cause of ill health in HD patients so a well functioning fistula is very important. A treatment called Far Infra Red (FIR) therapy has been shown to preserve the health of fistulas in patients already using them for HD. Our study aims to see whether FIR can also help the development of newly-formed fistulas in the 6 weeks after they have been created. Participants in the study will be randomised to either continue usual care (the control group) or to receive FIR therapy, using a FIR lamp, 5 times a week, at home for 6 weeks after surgery. The development of fistulas in the two groups will be compared using ultrasound scanning, 6 and 12 weeks after surgery.

Previous hypothesis:
Haemodialysis (HD) removes poisons from a patient's blood stream when their kidneys no longer work. The best way of getting 'access' to blood is through a permanent fistula, formed by surgically connecting a patient's artery and vein.

Poor 'access' is a major cause of ill health in HD patients so a well functioning fistula is very important. A treatment called Far Infra Red (FIR) therapy has been shown to preserve the health of fistulas in patients already using them for HD. Our study aims to see whether FIR can also help the development of fistulas before they are needed for dialysis, in the 6 weeks after they have been created. Participants in the study will be randomised to either continue usual care (the control group) or to receive FIR therapy, using a FIR lamp, 5 times a week, at home for 6 weeks after surgery. The development of fistulas in the two groups will be compared using ultrasound scanning, 6 and 12 weeks after surgery.

More details can be found at:http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14042

On 15/09/2014 the following changes were made to the trial record:
1. The public title was changed from 'Home Far Infra-red (FIR) therapy for Arterio-venous Fistulas (AVFs)' to 'Frequent, far infra-red (FIR) therapy for newly formed arterio-venous fistulas in dialysis and pre-dialysis patients.'
2. The scientific title was changed from 'Home Far Infra-red (FIR) Therapy for newly formed Arterio-venous Fistulas in pre-dialysis patients' to 'Frequent, far infra-red (FIR) therapy for newly formed arterio-venous fistulas in dialysis and pre-dialysis patients.'
3. The anticipated end date was changed from 30/04/2015 to 31/10/2017.

Ethics approval

NRES Committee North East - Newcastle and North Tyneside 2, favourable opinion given 22/05/2013, REC ref: 13/NE/0054; favourable opinion on substantial amendment (to broaden participation) given 11/09/2014

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal

Intervention

Current interventions as of 15/09/2014:
Pre-dialysis or dialysis patients awaiting AV fistula formation and randomised on a 1:1 basis between treatment and control groups.

Far infrared (FIR) therapy, 40-minute FIR therapy sessions, administered using a FIR lamp, five times a week for 6 weeks after AV fistula surgery.

Follow-up length: 3 months
Study entry: single randomisation only

Previous interventions:
Pre-dialysis patients awaiting AV fistula formation and randomised on a 1:1 basis between treatment and control groups.

Far infrared (FIR) therapy, 40-minute FIR therapy sessions, administered using a FIR lamp, five times a week for 6 weeks after AV fistula surgery.

Follow-up length: 3 months
Study entry: single randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Access flow at 6 weeks measured by ultrasound

Secondary outcome measures

Access flow at 12 weeks after AV fistula formation measured by ultrasound

Overall trial start date

01/05/2013

Overall trial end date

31/10/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 15/09/2014:
1. Pre-dialysis or dialysis patients undergoing formation of a brachial arterio-venous fistula
2. Ability to provide informed consent
3. Male and female, age >= 18 years

Previous inclusion criteria:
1. Pre-dialysis patients undergoing formation of a brachial arterio-venous fistula
2. Ability to provide informed consent
3. Male and female, age >= 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 72

Participant exclusion criteria

1. Impaired conscious level at the time of 1st FIR therapy
2. Impaired peripheral sensation

Recruitment start date

01/05/2013

Recruitment end date

31/10/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Freeman Road
Newcastle upon Tyne
NE7 7DN
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Charity

Funder name

Northern Counties Kidney Research Fund (UK)

Alternative name(s)

NCKRF

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Stanningley Pharma Ltd (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