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

Low Cardiac Output Syndrome Clinical Trial

— Levomil  

Official title:

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.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00549107
• Other study ID #: 1-365
• Status: Unknown status
• Phase: Phase 2
• First received: October 24, 2007
• Last updated: October 24, 2007
• Start date: September 2007

Study information

• Verified date: October 2007
• Source: Ludwig Boltzmann Gesellschaft
• Contact: Evelyn Lechner, MD
• Phone: +43505546324706
• Email: elechner[@]aon.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Output, Low
• Low Cardiac Output Syndrome
• Syndrome

Intervention

Drug:
• Levosimendan

• Milrinone

Locations

Country	Name	City	State
Austria	Children´s Heart Center Linz	Linz

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig Boltzmann Gesellschaft

Country where clinical trial is conducted

Austria, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Erratum in: Pediatr Crit Care Med. 2007 Mar;8(2):197. — View Citation

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. — View Citation

Wernovsky G, Wypij D, Jonas RA, Mayer JE Jr, Hanley FL, Hickey PR, Walsh AZ, Chang AC, Castañeda 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output measured by a transesophageal probe		48 hours
Secondary	Changes in mixed venous saturation		48 hours
Secondary	Serum lactate levels		48 hours
Secondary	Cardiac output and ventricular function assessed by echocardiography		48 hours
Secondary	Mean arterial, left atrial and central venous pressure		48 hours
Secondary	Need of catecholamines assessed with the inotropic score		48 hours
Secondary	Urine output		48 hours