Neuro-endocrine and immuno-systems activation during coronary surgery
| ISRCTN | ISRCTN78040136 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78040136 |
| Protocol serial number | N0264149435 |
| Sponsor | Department of Health |
| Funders | United Bristol Healthcare NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 15/03/2016
- 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 R Ascione
Scientific
Scientific
c/o Research & Effectiveness Department
Level 1, The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom
| Phone | +44 (0)117 928 3473 |
|---|---|
| r&eoffice@ubht.swest.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Neuro-endocrine and immuno-systems activation during coronary surgery |
| Study objectives | To ascertain the effects of cardiopulmonary bypass (CPB) and cardioplegic arrest on the activation of the hypothalmic-pituatary-adrenal (HPA) system and on the relations between neuro endocrine and immune systems |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Coronary artery bypass grafting (CABG) |
| Intervention | Prospective randomised study patients randomised to: 1. With cardiopulmonary bypass 2. Without cardiopulmonary bypass |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
To characterise the HPA system response during coronary surgery with or without cardiopulmonary bypass. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 80 |
| Key inclusion criteria | 80 patients admitted for first time coronary artery surgery suitable for on or off CPB surgery |
| Key exclusion criteria | 1. Single vessel coronary disease 2. Emergency referral 3. Previous Coronary Artery Graft Bypass (CAGB) 4. Evidence of severe thoracic disease |
| Date of first enrolment | 01/08/2004 |
| Date of final enrolment | 31/07/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
c/o Research & Effectiveness Department
Bristol
BS2 8HW
United Kingdom
BS2 8HW
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 |
Editorial Notes
15/03/2016: No publications found, verifying study status with principal investigator
