Ignite Creation Date:
2024-05-06 @ 12:10 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01500785
Status:
TERMINATED
Last Update Posted:
2019-09-13
First Post:
2011-12-22
Brief Title:
Intracoronary Administration of Levosimendan in Cardiac Surgery Patients
Sponsor:
Tampere University Hospital
Organization:
Tampere University Hospital
Study Overview
Official Title:
Intracoronary Administration of Levosimendan in Cardiac Surgery Patients
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change of schedule
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Incomplete recovery from ischemia causes stunned myocardium Ischemia may be due to coronary artery disease or aortic cross-clamping during surgery Stunning leads to myocardial dysfunction It has been suggested that the mechanism responsible for the contractile depression in stunned myocardium is a decreased sensitivity of the myofibrils to calcium Levosimendan is a calcium sensitizer which has been shown to improve the function of stunned myocardium without obvious impairment of diastolic function Systemic vasodilation and need of vasoconstrictive medication is usually apparent after administration of levosimendan Colucci et al have demonstrated that with intracoronary administration of milrinone another inodilator systemic vasodilation could be excluded If this is true with levosimendan it may be possible to improve left ventricular hypodyskinesia without afterload reduction by adding levosimendan into cardioplegia solution
The investigators hypotize that levosimendan delivered together with cardioplegia can improve LV dysfunction after opening of aortic cross-clamp in patients undergoing aortic valve and coronary artery bypass operation Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline Secondary endpoints are a change in LV ejection fraction from baseline to 5 min after sternal closure and cTnTCK-MB on the first postoperative morning
The investigators hypotize that levosimendan delivered together with cardioplegia can improve LV dysfunction after opening of aortic cross-clamp in patients undergoing aortic valve and coronary artery bypass operation Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline Secondary endpoints are a change in LV ejection fraction from baseline to 5 min after sternal closure and cTnTCK-MB on the first postoperative morning
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-002643-10 | EUDRACT_NUMBER | None | None |