Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants (Levomil)

Ludwig Boltzmann Gesellschaft

Status and phase: Unknown; Phase 2

Conditions: Low Cardiac Output Syndrome

Treatments: Drug: Milrinone; Drug: Levosimendan

Study type: Interventional

Funder types: Other

Identifiers

NCT00549107

1-365

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 1 day to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Levosimendan

2

Active Comparator group

Treatment:

Drug: Milrinone