Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Systemic inflammatory response is associated with cardiac surgery. Mediators liberated include cytokines and histamine. Histamine is associated with systemic effects like vasodilatation and cardiac dysrhythmias.
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
Treatment
Patient information sheet
Condition
Cardiovascular disease
Intervention
Patients will be randomly allocated into two groups.
Group H: this group will receive prophylactic H1- and H2-blockade
Group O: control group with no H1- and H2-blockade (placebo)
The study will be double blinded.
Intervention type
Drug
Phase
Not Specified
Drug names
H1 and H2 blockers
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2005
Overall trial end date
01/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Entry criteria: Patients presenting for elective coronary artery bypass grafting (CABG) and valve surgeries using cardiopulmonary bypass.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
80
Participant exclusion criteria
1. Patients on heparin or nitrate infusions
2. Patients with known allergies
3. Known asthmatics and patients with severe chronic obstructive pulmonary disease (COPD)
4. Patients on steroids or other immunosuppressive drugs
5. Emergency procedures or re-do operations
6. Patients on regular H1 or H2 blockers
Recruitment start date
01/02/2005
Recruitment end date
01/01/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital of Wales
Cardiff
CF4 4XW
United Kingdom
Sponsor information
Organisation
University of Wales College of Medicine, UK
Sponsor details
Heath Park
Cardiff
CF4 4XW
United Kingdom
HumphreysJM@cf.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Wales College of Medicine (UWCM) Endowment Fund, 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