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Pediatric patients, especially infants undergoing open heart surgery have a predictable fall in cardiac index 6 to 18 hours after surgery, the so-called low cardiac output syndrome (LCOS). Patients, who have LCOS require more monitoring, more medication and a longer stay in intensive care unit. To prevent LCOS the phosphodiesterase inhibitor milrinone is routinely used during the first 24 hours after surgery. Levosimendan, a calcium- sensitizer improves cardiac muscle contractile force, vascular smooth muscle relaxation and coronary blood flow through calcium sensitization of the myocardial contractile filaments and opening of potassium channels without increasing oxygen consumption of the heart muscle cells. As the myocardium of infants is more calcium dependent than in later life, levosimendan should be of special benefit in this age group. The purpose of this study is to investigate whether levosimendan is superior to milrinone in preventing LCOS in infants after corrective open heart surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levosimendan | Drug |
| ||
| Milrinone |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac output measured by a transesophageal probe | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in mixed venous saturation | 48 hours | |
| Serum lactate levels | 48 hours | |
| Cardiac output and ventricular function assessed by echocardiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evelyn Lechner, MD | Contact | +43505546324706 | elechner@aon.at | |
| Hans Gombotz, MD, PHD | Contact | +4373278062157 | hans.gombotz@akh.linz.at |
| Name | Affiliation | Role |
|---|---|---|
| Evelyn Lechner, MD | Children“s Heart Center Linz | Principal Investigator |
| Hans Gombotz, MD, PHD | General Hospital Linz, Ludwig Boltzmann Gesellschaft | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children“s Heart Center Linz | Recruiting | Linz | 4020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7554206 | Background | Wernovsky G, Wypij D, Jonas RA, Mayer JE Jr, Hanley FL, Hickey PR, Walsh AZ, Chang AC, Castaneda AR, Newburger JW, Wessel DL. Postoperative course and hemodynamic profile after the arterial switch operation in neonates and infants. A comparison of low-flow cardiopulmonary bypass and circulatory arrest. Circulation. 1995 Oct 15;92(8):2226-35. doi: 10.1161/01.cir.92.8.2226. | |
| 12600913 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 2, 2011 | |
| Reset | Feb 25, 2011 | |
| Release | Oct 22, 2011 | |
| Reset | Nov 28, 2011 | |
| Release | Oct 13, 2012 | |
| Reset | Nov 14, 2012 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 2, 2011 | Feb 25, 2011 | |||
| Oct 22, 2011 |
| ID | Term |
|---|---|
| D002303 | Cardiac Output, Low |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077464 | Simendan |
| D020105 | Milrinone |
| ID | Term |
|---|---|
| D006835 | Hydrazones |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D011724 | Pyridazines |
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|
| 48 hours |
| Mean arterial, left atrial and central venous pressure | 48 hours |
| Need of catecholamines assessed with the inotropic score | 48 hours |
| Urine output | 48 hours |
| Anna Hofer, MD |
| General Hospital Linz |
| Principal Investigator |
| Gerald Tulzer, MD, PHD | Children“s Heart Center Linz | Study Chair |
| Background |
| Hoffman TM, Wernovsky G, Atz AM, Kulik TJ, Nelson DP, Chang AC, Bailey JM, Akbary A, Kocsis JF, Kaczmarek R, Spray TL, Wessel DL. Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation. 2003 Feb 25;107(7):996-1002. doi: 10.1161/01.cir.0000051365.81920.28. |
| 15329162 | Background | Turanlahti M, Boldt T, Palkama T, Antila S, Lehtonen L, Pesonen E. Pharmacokinetics of levosimendan in pediatric patients evaluated for cardiac surgery. Pediatr Crit Care Med. 2004 Sep;5(5):457-62. doi: 10.1097/01.pcc.0000137355.01277.9c. |
| 16672640 | Background | Egan JR, Clarke AJ, Williams S, Cole AD, Ayer J, Jacobe S, Chard RB, Winlaw DS. Levosimendan for low cardiac output: a pediatric experience. J Intensive Care Med. 2006 May-Jun;21(3):183-7. doi: 10.1177/0885066606287039. |
| 16885788 | Background | Namachivayam P, Crossland DS, Butt WW, Shekerdemian LS. Early experience with Levosimendan in children with ventricular dysfunction. Pediatr Crit Care Med. 2006 Sep;7(5):445-8. doi: 10.1097/01.PCC.0000235251.14491.75. |
| Nov 28, 2011 |
| Oct 13, 2012 | Nov 14, 2012 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000676 | Amrinone |
| D000631 | Aminopyridines |
| D000588 | Amines |
| D011725 | Pyridines |