Clinical trial NCT00549107: Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Low Cardiac Output Syndrome
Keywords: low cardiac output syndrome
open heart surgery
infants
Low cardiac output syndrome in infants undergoing corrective open heart surgery
Lead sponsor: Ludwig Boltzmann Gesellschaft
Sponsor class: OTHER
First posted: 2007-10-25
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Cardiac output measured by a transesophageal probe
timeFrame: 48 hours
Secondary outcomes:
measure: Changes in mixed venous saturation
timeFrame: 48 hours
measure: Serum lactate levels
timeFrame: 48 hours
measure: Cardiac output and ventricular function assessed by echocardiography
timeFrame: 48 hours
measure: Mean arterial, left atrial and central venous pressure
timeFrame: 48 hours
measure: Need of catecholamines assessed with the inotropic score
timeFrame: 48 hours
measure: Urine output
timeFrame: 48 hours
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Children´s Heart Center Linz
Study officials:
affiliation: Children´s Heart Center Linz
name: Evelyn Lechner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital Linz, Ludwig Boltzmann Gesellschaft
name: Hans Gombotz, MD, PHD
role: STUDY_DIRECTOR
affiliation: General Hospital Linz
name: Anna Hofer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children´s Heart Center Linz
name: Gerald Tulzer, MD, PHD
role: STUDY_CHAIR
References:
citation: 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.
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. doi: 10.1161/01.cir.0000051365.81920.28.
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. doi: 10.1097/01.pcc.0000137355.01277.9c.
citation: 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.
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. doi: 10.1097/01.PCC.0000235251.14491.75.