The role of Oxidant Stress on the induction of the Inflammatory Reaction by Cardiopulmonary Bypass
| ISRCTN | ISRCTN76622877 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76622877 |
| Protocol serial number | N0123138565 |
| Sponsor | Department of Health |
| Funder | University Hospitals of Leicester NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Proinflammatory cytokines, antioxidant capacity, oxygen free radicals and clinical outcomes. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
