A randomised trial using Zero-Balanced Ultrafiltration in Cardiopulmonary bypass
| ISRCTN | ISRCTN42496709 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42496709 |
| Secondary identifying numbers | N0123138588 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 19/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Mr D Machin
Scientific
Scientific
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
| Phone | +44 (0)116 258 4109 |
|---|---|
| nicola.turner@uhl-tr.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomised trial using Zero-Balanced Ultrafiltration in Cardiopulmonary bypass |
| Study objectives | To show whether a modified method of ultrafiltration, known as Zero-balance ultrafiltration (ZBUF) is effective in reducing free-radical production during cardiac surgery in adults. A reduction in free radical generation will help protect cell membranes |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular surgery |
| Intervention | Clinical Study|Human Physiology|Inpatient Admission|Multicentre Study: National|NHS Patients|Study of Non-Therapeutic Procedure |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | To establish the effects of Zero-balanced Ultrafiltration with patients in cardiopulmonary bypass |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/2003 |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Less than 75 years of age 2. Left ventricular function less than 50% 3. Pre-operative haematocrit greater than 30%. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/08/2003 |
| Date of final enrolment | 01/06/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
University Hospitals of Leicester 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 |
Editorial Notes
19/04/2018: No publications found, study status unverified.
04/03/2016: No publications found, verifying study status with principal investigator.
