Organ protection by noble gases – A clinical study to investigate Helium induced Pre- and Postconditioning in patients undergoing coronary artery bypass surgery (HIPP-CABG). - Helium induced Pre and Postconditioning
- Conditions
- patients undergoing coronary artery bypass surgery, helium induced pre- and postconditioning
- Registration Number
- EUCTR2008-000992-12-NL
- Lead Sponsor
- Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
•Age: = 18 Years
•Patients who have to undergo elective cardiac surgery (CABG without valve surgery)
•Written informed consent
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
•Age = 18 years
•Emergency operations
•Pregnancy
•Severe COPD
•Absent informed consent
•SaO2 < 90% at room temperature
•Presumed non cooperatives
•Legal incapacity
•Diabetes Mellitus
•Renal failure, liver failure
•Combined valve and coronary artery procedures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate whether helium induced molecular changes in the myocardium after pre- and postconditioning in patients undergoing coronary artery bypass surgery;Secondary Objective: to measure release of cardiac enzymes as markers of myocardial ischemia;Primary end point(s): Main study parameters are detection of signalling pathway molecules involved in anaesthetic preconditioning (PKC-e, p38MAPK, ERK and HSP27). This will be done by molecular analysis of myocardial tissue samples in our laboratory.
- Secondary Outcome Measures
Name Time Method