| Source of record | UK Trials |
| ISRCTN | ISRCTN76622877 |
| Date ISRCTN assigned | 30/09/2004 |
| Local reference number(s) | N0123138565 |
| Public title | The role of Oxidant Stress on the induction of the Inflammatory Reaction by Cardiopulmonary Bypass |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Surgery: Cardiovascular |
| Study hypothesis | 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 |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients with ischaemic heart disease (IHD) scheduled for elective cardiac operations will be selected. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 05/12/2003 |
| Anticipated end date | 30/09/2006 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Proinflammatory cytokines, antioxidant capacity, oxygen free radicals and clinical outcomes. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | University Hospitals of Leicester NHS Trust (UK) |
| Sponsor name | Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr B Matata |
| Contact details | University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
United Kingdom
LE1 4PW |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN76622877 |
| Date last extracted from ISRCTN register | 17/04/2008 |
