Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants - Full Text View

Sponsored by:	Ludwig Boltzmann Gesellschaft
Information provided by:	Ludwig Boltzmann Gesellschaft
ClinicalTrials.gov Identifier:	NCT00549107

Purpose

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.

Condition	Intervention	Phase
Low Cardiac Output Syndrome	Drug: Levosimendan Drug: Milrinone	Phase II

MedlinePlus related topics: Heart Failure Heart Surgery

Drug Information available for: Levosimendan Simendan Milrinone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Ludwig Boltzmann Gesellschaft:

Primary Outcome Measures:

Cardiac output measured by a transesophageal probe [ Time Frame: 48 hours ]

Secondary Outcome Measures:

Changes in mixed venous saturation [ Time Frame: 48 hours ]
Serum lactate levels [ Time Frame: 48 hours ]
Cardiac output and ventricular function assessed by echocardiography [ Time Frame: 48 hours ]
Mean arterial, left atrial and central venous pressure [ Time Frame: 48 hours ]
Need of catecholamines assessed with the inotropic score [ Time Frame: 48 hours ]
Urine output [ Time Frame: 48 hours ]

Estimated Enrollment:	40
Study Start Date:	September 2007

Arms	Assigned Interventions
1: Experimental	Drug: Levosimendan
2: Active Comparator	Drug: Milrinone

Eligibility

Ages Eligible for Study:	up to 12 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549107

Contacts

Contact: Evelyn Lechner, MD	+43505546324706	elechner@aon.at
Contact: Hans Gombotz, MD, PHD	+4373278062157	hans.gombotz@akh.linz.at

Locations

Austria
Children´s Heart Center Linz	Recruiting
Linz, Austria, 4020
Contact: Evelyn Lechner, MD elechner@aon.at
Contact: Anna Hofer, MD anna.hofer@akh.linzat
Principal Investigator: Evelyn Lechner, MD
Principal Investigator: Anna Hofer, MD

Sponsors and Collaborators

Ludwig Boltzmann Gesellschaft

Investigators

Principal Investigator:	Evelyn Lechner, MD	Children´s Heart Center Linz
Study Director:	Hans Gombotz, MD, PHD	General Hospital Linz, Ludwig Boltzmann Gesellschaft
Principal Investigator:	Anna Hofer, MD	General Hospital Linz
Study Chair:	Gerald Tulzer, MD, PHD	Children´s Heart Center Linz

More Information

Publications:

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.

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.

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.

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.

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.

Study ID Numbers:	1-365
Study First Received:	October 24, 2007
Last Updated:	October 24, 2007
ClinicalTrials.gov Identifier:	NCT00549107
Health Authority:	Austria: Ethikkommission

Keywords provided by Ludwig Boltzmann Gesellschaft:

low cardiac output syndrome
open heart surgery
infants
Low cardiac output syndrome in infants undergoing corrective open heart surgery

Study placed in the following topic categories:

Signs and Symptoms
Heart Diseases
Milrinone
Simendan
Cardiac Output, Low

Additional relevant MeSH terms:

Vasodilator Agents
Disease
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Physiological Effects of Drugs
Hematologic Agents
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents

Pharmacologic Actions
Pathologic Processes
Phosphodiesterase Inhibitors
Syndrome
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 15, 2009