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Clinical Trial Name - Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants

 
Original Study ID : 1-365
NCT ID : NCT00549107
Brief Title : 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.
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.

Source : Ludwig Boltzmann Gesellschaft
Overall Status : Recruiting
Start Date : September 2007
Official Title : Phase 2
Phase : Interventional
Study Design : Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Enrollment : 40
Verification Date : October 2007
First Received Date : October 24, 2007
Trial 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
Gender : Both
Minimum Age : N/A
Maximum Age : 12 Months
Healthy Volunteers : No
Facilities
Facility Name : Children“s Heart Center Linz
Status : Recruiting
City : Linz
Zip Code : 4020
Country : Austria
Refferances
PMID : 7554206
Citation : Wernovsky G, Wypij D, Jonas RA, Mayer JE Jr, Hanley FL, Hickey PR, Walsh AZ, Chang AC, Castaneda AR, Newburger JW, et al. 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.
PMID : 12600913
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.
PMID : 15329162
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.
PMID : 16672640
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.
PMID : 16885788
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.
OutComes
Primary OutComes
Measure : Cardiac output measured by a transesophageal probe
Time Frame : 48 hours
Secondary OutComes
Measure : Changes in mixed venous saturation
Time Frame : 48 hours
Measure : Serum lactate levels
Time Frame : 48 hours
Measure : Cardiac output and ventricular function assessed by echocardiography
Time Frame : 48 hours
Measure : Mean arterial, left atrial and central venous pressure
Time Frame : 48 hours
Measure : Need of catecholamines assessed with the inotropic score
Time Frame : 48 hours
Measure : Urine output
Time Frame : 48 hours
Interventions
Type : Drug
Name : Levosimendan
Type : Drug
Name : Milrinone
 
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