Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buckberg cardioplegia | Experimental |
| |
| St Thomas´ cardioplegia | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Buckberg cardioplegic solution | Drug | Study subjects randomized to this study group will receive Modified Buckberg cardioplegic solution during coronary artery bypass grafting operation. |
| Measure | Description | Time Frame |
|---|---|---|
| CKMB | Peak plasma levels of Creatin kinase muscle brain 0,18-300 µg/L | 48 hours after surgery (cross clamp release) |
| Measure | Description | Time Frame |
|---|---|---|
| hs-cTnT | peak level of plasma hig sensitive cardiac Troponin T after surgery 3 - 10 000 ng/L | 48 hours after surgery (cross clamp release) |
| hs-cTnI | peak plasma level of high sensitive cardiac Troponin I after surgery 2,50-25 000 ng/L |
Not provided
Inclusion Criteria:
Exclusion Criteria: *Heart failure (=Left ventricular ejection fraction less than 40 %).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Snejana Hyllén, MD, Assistant Professor | Region Skane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiothoracic surgery department, Skåne university hospital, Lund | Lund | 22242 | Sweden |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 1, 2021 | Jan 27, 2026 | ICF_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
| Modified St Thomas´ cardioplegic solution | Drug | Study subjects randomized to this study group will receive Modified St Thomas hospital´s cardioplegic solution during coronary artery bypass grafting operation. |
|
| 48 hours after surgery (cross clamp release) |
| Pacemaker | Rate of required use of temporary pacemaker after aortic cross clamp release | two hours after aortic cross clamp release |
| DC cardioversion | Rate of required use of direct current cardioversion to treat arrythmia after aortic cross clamp release | during the surgical procedure in the operating room |
| Cardiometabolic protein profile | Levels of 92 cardiometabolic proteins analyzed with proximity extension assay technique before and two hours after surgery. | 2 hours after surgery |