Condition category
Circulatory System
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
Low blood pressure is the most common complication for patients attending for routine outpatient haemodialysis treatments (filtering out waste products from the blood). Low blood pressure could be due to too low a blood volume, but could also be due to relaxation of the blood vessels. We wish to measure blood pressure during dialysis with a more sophisticated blood pressure machine that provides information about the stiffness of the major arteries to see whether there is relaxation of these arteries occurring before a fall in blood pressure.

Who can participate?
Patients with long-term kidney disease who are treated by regular outpatient haemodialysis in the Royal Free Hospital can participate in the study.

What does the study involve ?
When patients come for haemodialysis we will use a standard blood pressure cuff placed on the upper arm which is linked to a blood pressure machine and a computer that can measure pulse wave velocity. This equipment is currently used in routine clinical practice. The only difference compared to a standard blood pressure machine is that the blood pressure cuff inflates three times. As with standard practice, blood pressure will be measured before dialysis, at 20 minutes, then hourly. If you have not had a recent electrical recording of the heart (ECG) we will perform one.

What are the possible benefits and risks of participating?
There may be no immediate benefits to any patient. No additional blood tests are required, and the blood pressure test is non-invasive and does not cause pain and is performed whilst patients are having dialysis. Similarly if an ECG is recorded, this is painless and can be done during the dialysis treatment.

Where is the study run from?
The study is run from the UCL Centre for Nephrology at the Royal Free Hospital, UK.

When is study starting and how long is it expected to run for?
The study starts in January 2013 is expected to end in late 2014.

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
NW3 2QG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

protocol version 4

Study information

Scientific title

Study to determine whether changes in pulse wave velocity are associated with changes in blood pressure in haemodialysis patients

Acronym

Study hypothesis

Do changes in major arterial compliance occur during haemodialysis and does this lead to low blood pressure during haemodialysis?

Ethics approval

London Central Ethics Committee; September 2012; 12/LO/0976

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

Measurement of pulse wave velocity

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Blood pressure and pulse wave velocity
Blood pressure will be measured at the start of a dialysis session, then at 20 minutes, one hour and then hourly during the dialysis session. Changes in pulse wave velocity and heartbeat variation will be reviewed to determine whether these are related to changes in blood pressure during the dialysis session.

Secondary outcome measures

Derived variables from pulse wave velocity

Overall trial start date

01/01/2013

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with chronic kidney disease treated by haemodialysis
2. Patients who are able to provide valid consent
3. Patients who can have their blood pressure measured using an arm blood pressure cuff

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

More than 100

Participant exclusion criteria

1. Patients who do not fulfil the inclusion criteria
2. Patients who cannot provide valid informed consent
3. Patients who cannot have their blood pressure measured using an upper arm blood pressure cuff
4. Those with atrial fibrillation and other cardiac arrhythmias

Recruitment start date

01/01/2013

Recruitment end date

31/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UCL Centre for Nephrology
London
NW3 2QG
United Kingdom

Sponsor information

Organisation

Royal Free Hospital (UK)

Sponsor details

Pond street
London
NW32QG
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