Contact information
Type
Scientific
Primary contact
Dr R Ascione
ORCID ID
Contact details
c/o Research & Effectiveness Department
Level 1
The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 3473
r&eoffice@ubht.swest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0264149435
Study information
Scientific title
Neuro-endocrine and immuno-systems activation during coronary surgery
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Coronary artery bypass grafting (CABG)
Intervention
Prospective randomised study patients randomised to:
1. With cardiopulmonary bypass
2. Without cardiopulmonary bypass
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
To characterise the HPA system response during coronary surgery with or without cardiopulmonary bypass.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2004
Overall trial end date
31/07/2005
Reason abandoned
Eligibility
Participant inclusion criteria
80 patients admitted for first time coronary artery surgery suitable for on or off CPB surgery
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
80
Participant exclusion criteria
1. Single vessel coronary disease
2. Emergency referral
3. Previous Coronary Artery Graft Bypass (CAGB)
4. Evidence of severe thoracic disease
Recruitment start date
01/08/2004
Recruitment end date
31/07/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
c/o Research & Effectiveness Department
Bristol
BS2 8HW
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
United Bristol Healthcare NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary