To determine whether changes in pulse wave velocity predict hypotension during dialysis
| ISRCTN | ISRCTN12870218 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12870218 |
| Secondary identifying numbers | protocol version 4 |
- Submission date
- 11/10/2013
- Registration date
- 01/11/2013
- Last edited
- 17/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
UCL Centre for Nephrology
Royal Free Hospital
Pond St
London
NW3 2QG
United Kingdom
Study information
| Study design | Prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN12870218_PIS_09Aug12_V4.doc |
| Scientific title | Study to determine whether changes in pulse wave velocity are associated with changes in blood pressure in haemodialysis patients |
| Study objectives | Do changes in major arterial compliance occur during haemodialysis and does this lead to low blood pressure during haemodialysis? |
| Ethics approval(s) | London Central Ethics Committee, 05/09/2012, ref: 12/LO/0976 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2013 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | More than 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Pond St
London
NW3 2QG
United Kingdom
Sponsor information
Hospital/treatment centre
Pond street
London
NW32QG
England
United Kingdom
"ROR" |
https://ror.org/01ge67z96 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2013 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/09/2013 | Yes | No | |
| Participant information sheet | version V4 | 09/08/2012 | 17/01/2017 | No | Yes |
Additional files
- ISRCTN12870218_PIS_09Aug12_V4.doc
- Uploaded 17/01/2017
Editorial Notes
17/01/2017: The participant information sheet has been uploaded and the date of ethical approval has been added.
13/01/2017: Publication reference added.
