Cellular stress and inflammation with miniature cardiopulmonary bypass
| ISRCTN | ISRCTN30610605 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30610605 |
| Protocol serial number | 7937 |
| Sponsor | Imperial College NHS Healthcare Trust (UK) |
| Funder | Heart Research UK (UK) |
- Submission date
- 12/05/2010
- Registration date
- 12/05/2010
- Last edited
- 11/08/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Bao Nguyen
Scientific
Scientific
Department of Cardiothoracic Sciences
National Heart and Lung Institute
Hammersmith Hospital
Du Cane Road
London
W12 0NN
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised interventional diagnosis, prevention, process of care and treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Does mini-cardiopulmonary bypass (CPB) reduce cellular stress and inflammation compared with standard CPB? |
| Study objectives | Ischaemia-reperfusion, mechanical trauma and other stimuli associated with cardiopulmonary bypass (CPB) can lead to the generation of intracellular reactive oxygen species (ROS). ROS can enhance inflammatory activation via activation of NF-kB, p38 MAP kinase and other pathways. Given that CPB leads to ischaemia and mechanical stimulation of leucocytes, it is likely to induce ROS in leukocytes and other cell types. Hypotheses: 1. CPB leads to rapid induction of ROS in leukocytes which is associated with early activation of pro-inflammatory signalling (e.g. p38 activation) and with delayed activation of anti-inflammatory/anti-oxidant mechanisms 2. Mini-CPB is associated with reduced ROS/pro-inflammatory activation in leucocytes and attenuated systemic inflammation compared to conventional CPB |
| Ethics approval(s) | Brompton, Harefield and NHLI Research Ethics Committee, 24/07/2008, ref: 08/H0708/67. Amendment approved on 29/04/2010, ref: AM02. |
| Health condition(s) or problem(s) studied | Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular |
| Intervention | All patients referred for primary elective coronary artery bypass grafting (CABG) will be considered for inclusion within the clinical trial. Trial participants will be randomised into one of three different treatment groups: 1. Positive control group in whom standard CPB is used 2. Negative control group in whom CPB is not used at all ('off pump' group) 3. Investigative group in which the mini-CPB technique is used ('miniCPB' group) Participants will be reviewed up until they are discharged from hospital. Intervention timings are as follows: Blood tests: 1. Pre-op (baseline) 2. Post induction 3. Start of CPB 4. 15 minutes CPB 5. 30 minutes CPB 6. 45 minutes CPB 7. 60 minutes CPB 8. 2 hours CPB 9. 6 hours CPB 10. 24 hours CPB Cantharadin blister tests: 1. Pre-op (baseline) 2. CPB 5 hours Myocardial tissue sampling: 1. Start of CPB 2. Before end of CPB |
| Intervention type | Other |
| Primary outcome measure(s) |
Blood parameters of cellular stress - reactive oxygen species detection; p38 MAP kinase signalling |
| Key secondary outcome measure(s) |
Supporting conventional markers of the inflammatory response will be measured including white cell count |
| Completion date | 01/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 48 |
| Key inclusion criteria | 1. Age range 18+ years 2. No gender discrimination 3. Patients referred for elective coronary artery bypass grafting (CABG) 4. Not participated in any other clinical trial |
| Key exclusion criteria | 1. Patients less than 18 years of age 2. Emergency cases 3. Combined valvular procedures 4. Redo operations 5. Poor left ventricular function (ejection fraction less than 30%) 6. Cerebro-vascular accident within 3 months pre-operatively or more than 75% carotid artery obstruction as shown by carotid Doppler scan 7. Serum creatinine in excess of 177 μmol/L 8. Pre-existing coagulopathy 9. Pre-existing liver dysfunction 10. Recent (within 5 days) use of antiplatelets (aspirin/clopidogrel) |
| Date of first enrolment | 01/06/2010 |
| Date of final enrolment | 01/06/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Cardiothoracic Sciences
London
W12 0NN
United Kingdom
W12 0NN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | substudy results | 01/10/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
