Neuro-endocrine and immuno-systems activation during coronary surgery

ISRCTN	ISRCTN78040136
DOI	https://doi.org/10.1186/ISRCTN78040136
Secondary identifying numbers	N0264149435

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

Dr R Ascione
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
Email	r&eoffice@ubht.swest.nhs.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
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	To characterise the HPA system response during coronary surgery with or without cardiopulmonary bypass.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/08/2004
Completion date	31/07/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	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

c/o Research & Effectiveness Department

Bristol
BS2 8HW
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Hospital/treatment centre

United Bristol Healthcare NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

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

15/03/2016: No publications found, verifying study status with principal investigator