The role of Oxidant Stress on the induction of the Inflammatory Reaction by Cardiopulmonary Bypass
| ISRCTN | ISRCTN76622877 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76622877 |
| Secondary identifying numbers | N0123138565 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 11/04/2014
- 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
Dr B Matata
Scientific
Scientific
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 1. To study the mechanism by which inflammatory response to cardiopulmonary bypass is modulated by oxidant stress 2. To use an ex-vivo model of cardiopulmonary bypass (CPB) and blood samples from patients to investigate oxygen free radicals on the pathogenesis |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Cardiovascular |
| Intervention | The project is composed of laboratory based investigation and the molecular changes associated with the re-circulation of blood in an artificial surface will be studied using a surrogate model of CPB. A total of 400 patients will be randomised to one of the groups: IHD with and without Hypertension, IHD with and without Hypercholesterolemia, IHD with and without Diabetes, Healthy control. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Proinflammatory cytokines, antioxidant capacity, oxygen free radicals and clinical outcomes. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 05/12/2003 |
| Completion date | 30/09/2006 |
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 with ischaemic heart disease (IHD) scheduled for elective cardiac operations will be selected. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 05/12/2003 |
| Date of final enrolment | 30/09/2006 |
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
Government
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 |
