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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig Boltzmann Gesellschaft
• Treatments: Milrinone; Simendan

Criteria

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