Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0123138565
Study information
Scientific title
Acronym
Study hypothesis
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
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
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Proinflammatory cytokines, antioxidant capacity, oxygen free radicals and clinical outcomes.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
05/12/2003
Overall trial end date
30/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with ischaemic heart disease (IHD) scheduled for elective cardiac operations will be selected.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
05/12/2003
Recruitment end date
30/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospitals of Leicester NHS Trust (UK)
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