Organ protection by noble gases * A clinical study to investigate Helium induced Pre- and Postconditioning in patients undergoing coronary artery bypass surgery.
Phase 2
- Conditions
- 1001108210007593coronary artery bypass grafting
- Registration Number
- NL-OMON31964
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 125
Inclusion Criteria
Age: * 18 Years, Patients who have to undergo elective cardiac surgery (CABG without valve surgery), Written informed consent
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters are detection of signalling pathway molecules involved in<br /><br>anaesthetic preconditioning (PKC-e, p38MAPK, ERK and HSP27). This will be done<br /><br>by molecular analysis of myocardial tissue samples in our laboratory. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters are cardiac enzyme release after surgery (troponine T,<br /><br>CPK, CK-MB) and haemodynamics during surgery measured by transoesophageal<br /><br>echocardiography (TEE). Furthermore, several biomarkers will be investigated to<br /><br>see whether helium has a protective effect against surgery induced tissue<br /><br>damage in other organs; urine N-acetyl-glucosaminase (NAG) to estimate kidney<br /><br>damage, Intestinal-type fatty acid binding protein (I-FABP)/liver-type fatty<br /><br>acid binding protein (L-FABP)/ heart-type fatty acid binding protein (H-FABP)<br /><br>to estimate intestinal injury, and *-glutathione S-transferase (*-GST) to<br /><br>estimate liver damage</p><br>