Study into myocardial stunning during haemodialysis and the effect of biofeedback haemodialysis
| ISRCTN | ISRCTN74583385 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74583385 |
| Secondary identifying numbers | N0077122814 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 16/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr CW McIntyre
Scientific
Scientific
Southern Derbyshire Acute Hospitals NHS Trust
Department of Nephrology
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
| Phone | +44 (0)1332 340131 |
|---|
Study information
| Study design | Randomised crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 1. Haemodialysis with ultrafiltration is capable of inducing myocardial stunning in individuals both with and without coronary artery disease 2. Myocardial stunning induced by haemodialysis may be ameliorated by the use of biofeedback-controlled haemodialysis, despite identical total ultrafiltration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Haemodialysis |
| Intervention | We propose to study chronic haemodialysis patients in a randomised crossover study. The first group will undergo an initial period of standard haemodialysis followed by a period of biofeedback-controlled haemodialysis. The second group will do the same in reverse. At the end of both periods, all patients will undergo echocardiography performed at regular intervals throughout a single haemodialysis session, and for a short period afterwards. They will also have Troponin T measured before and after the same dialysis session. |
| Intervention type | Other |
| Primary outcome measure | 1. Number of regional wall abnormalities/patient 2. Ejection and shortening fractions |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 21/02/2003 |
| Completion date | 01/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients on chronic haemodialysis |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 21/02/2003 |
| Date of final enrolment | 01/04/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Southern Derbyshire Acute Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
