Histamine Release and Implications of H1- and H2- Blockade in Adult Cardiac Surgery - A Randomised Controlled Study - Implications of H1- and H2- Blockade in Adult Cardiac Surgery
Phase 1
- Conditions
- During cardiac surgery involving the use of cardiopulmonary bypass histamine is released in the blood. Histamine release has been related to an increased incidence of perioperative dysrhythmias and may be involved in other complications. Our aim is to find out whether the use of histamine blocking drugs will prevent these arrhythmias. The study population will consist of adult patients who must undergo elective cardiac surgery in which the use of cardiopulmonary bypass is necessary
- Registration Number
- EUCTR2005-001291-12-GB
- Lead Sponsor
- Cardiff University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Patients presenting for elective cornary artery bypass graft (CABG) and valve surgeries that require the use of cardiopulmonary bypass
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Emergency procedures or re-do operations. Patients with known allergies, known asthmatics and patients with severe chronic obstructive pulmonary disease (COPD). Patients on steroids or other immunosuppressive drugs, on regular H1- or H2- blockers, on heparin or nitrate infusions.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method