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

NCT00549107 | Unknown Phase 2 DMC

• 1 other identifier: 1-365
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Cardiac output measured by a transesophageal probe

  48 hours

Secondary Outcomes (6)

• Changes in mixed venous saturation

  48 hours

• Serum lactate levels

  48 hours

• Cardiac output and ventricular function assessed by echocardiography

  48 hours

• Mean arterial, left atrial and central venous pressure

  48 hours

• Need of catecholamines assessed with the inotropic score

  48 hours

Study Arms (2)

1

EXPERIMENTAL

Drug: Levosimendan

2

ACTIVE COMPARATOR

Drug: Milrinone

Interventions

Levosimendan DRUG

1

Milrinone DRUG

2

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age younger than one year
• corrective open heart surgery with biventricular repair, except tetralogy of fallot

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig Boltzmann Gesellschaft: lead

Study Sites (1)

Children´s Heart Center Linz

Linz, 4020, Austria

RECRUITING

Related Publications (5)

• 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.

  PMID: 7554206 BACKGROUND

• 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.

  PMID: 12600913 BACKGROUND

• 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.

  PMID: 15329162 BACKGROUND

• 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.

  PMID: 16672640 BACKGROUND

• 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.

  PMID: 16885788 BACKGROUND

MeSH Terms

Conditions

Cardiac Output, Low

Interventions

Simendan; Milrinone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amrinone; Aminopyridines; Amines; Pyridines

Study Officials

• Evelyn Lechner, MD

  Children´s Heart Center Linz

  PRINCIPAL INVESTIGATOR

• Hans Gombotz, MD, PHD

  General Hospital Linz, Ludwig Boltzmann Gesellschaft

  STUDY DIRECTOR

• Anna Hofer, MD

  General Hospital Linz

  PRINCIPAL INVESTIGATOR

• Gerald Tulzer, MD, PHD

  Children´s Heart Center Linz

  STUDY CHAIR

Central Study Contacts

Evelyn Lechner, MD

CONTACT

+43505546324706; elechner@aon.at

Hans Gombotz, MD, PHD

CONTACT

+4373278062157; hans.gombotz@akh.linz.at

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 24, 2007
• First Posted: October 25, 2007
• Study Start: September 1, 2007
• Last Updated: October 25, 2007

Record last verified: 2007-10

Locations

AU (1)