Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants

Study Overview
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Brief Summary
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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.

Official Title
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Phase 2 Prospective, Randomized, Double-Blind Pilot Study on Cardiac Output Following Corrective Open Heart Surgery in Children Less Than One Year: Use of Levosimendan Versus Milrinone.

Conditions
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Low Cardiac Output Syndrome

Intervention / Treatment
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* Drug: Levosimendan
* Drug: Milrinone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age younger than one year corrective open heart surgery with biventricular repair, except tetralogy of fallot Exclusion Criteria: Missing written consent of parents Weight less than 3 kg preoperative LCOS gestational age less than 36 weeks preexisting renal failure preexisting thrombopenia preoperative cardiopulmonary resuscitation preoperative use of milrinone or levosimendan

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Levosimendan<br> <br> |
| Active Comparator: 2<br> | Drug: Milrinone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output measured by a transesophageal probe |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mixed venous saturation |  | 48 hours | 
| Serum lactate levels |  | 48 hours | 
| Cardiac output and ventricular function assessed by echocardiography |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low cardiac output syndrome, open heart surgery, infants, Low cardiac output syndrome in infants undergoing corrective open heart surgery