Cardioplegia, Cardiopulmonary Bypass, Coronary Artery Bypass Graft (CABG), Perioperative Myocardial Injury
Conditions
Brief summary
This study seek to compare two different solutions used to protect the heart during cardiac surgery. 40 adult patients planned for coronary artery bypass surgery with cardiopulmonary bypass machine assistance will be included in the study. Blood samples from the first 48 hours after surgery will be analyzed together with physical data, x-ray-results, ecg and general outcome after surgery.
Interventions
DRUGModified Buckberg cardioplegic solution
Study subjects randomized to this study group will receive Modified Buckberg cardioplegic solution during coronary artery bypass grafting operation.
DRUGModified St Thomas´ cardioplegic solution
Study subjects randomized to this study group will receive Modified St Thomas hospital´s cardioplegic solution during coronary artery bypass grafting operation.
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for non urgent, single procedure coronary artery bypass grafting surgery at Skåne university hospital in Lund Sweden
Exclusion criteria
\*Heart failure (=Left ventricular ejection fraction less than 40 %). * Moderate and severe aortic valve insufficiency. * Type 1 diabetes. * Renal insufficiency (=estimated glomerular filtration rate \<60 mL/min/1,73m2) * Not communicating in Swedish language. * Previous cardiac surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CKMB | 48 hours after surgery (cross clamp release) | Peak plasma levels of Creatin kinase muscle brain 0,18-300 µg/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hs-cTnT | 48 hours after surgery (cross clamp release) | peak level of plasma hig sensitive cardiac Troponin T after surgery 3 - 10 000 ng/L |
| hs-cTnI | 48 hours after surgery (cross clamp release) | peak plasma level of high sensitive cardiac Troponin I after surgery 2,50-25 000 ng/L |
| Pacemaker | two hours after aortic cross clamp release | Rate of required use of temporary pacemaker after aortic cross clamp release |
| DC cardioversion | during the surgical procedure in the operating room | Rate of required use of direct current cardioversion to treat arrythmia after aortic cross clamp release |
| Cardiometabolic protein profile | 2 hours after surgery | Levels of 92 cardiometabolic proteins analyzed with proximity extension assay technique before and two hours after surgery. |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORSnejana Hyllén, MD, Assistant Professor
Region Skåne
Outcome results
None listed