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
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, 05/09/2012, ref: 12/LO/0976
Study design
Prospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
See additional files
Condition
Haemodialysis
Intervention
All participants have a blood pressure cuff placed around their non fistula arm. Blood pressure measurements are taken three times spaced three minutes apart, during which time pulse wave velocity measurements are taken.
Post-dialysis, medical records are reviewed to see if there is any relationship to the changes of blood pressure during dialysis.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Blood pressure and pulse wave velocity are measured using a blood pressure cuff.
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 (if study stopped)
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
Royal Free Hospital
Pond St
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
Planned publication in a peer reviewed journal.
Intention to publish date
31/12/2013
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in https://www.ncbi.nlm.nih.gov/pubmed/24011131
Publication citations
Additional files
- ISRCTN12870218_PIS_09Aug12_V4.doc Uploaded 17/01/2017