Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants (Levomil)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00549107
Recruitment Status : Unknown
Verified October 2007 by Ludwig Boltzmann Gesellschaft.
Recruitment status was:  Recruiting
First Posted : October 25, 2007
Last Update Posted : October 25, 2007
Information provided by:
Ludwig Boltzmann Gesellschaft

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.

Condition or disease Intervention/treatment Phase
Low Cardiac Output Syndrome Drug: Levosimendan Drug: Milrinone Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Levosimendan
Active Comparator: 2 Drug: Milrinone

Primary Outcome Measures :
  1. Cardiac output measured by a transesophageal probe [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Changes in mixed venous saturation [ Time Frame: 48 hours ]
  2. Serum lactate levels [ Time Frame: 48 hours ]
  3. Cardiac output and ventricular function assessed by echocardiography [ Time Frame: 48 hours ]
  4. Mean arterial, left atrial and central venous pressure [ Time Frame: 48 hours ]
  5. Need of catecholamines assessed with the inotropic score [ Time Frame: 48 hours ]
  6. Urine output [ Time Frame: 48 hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00549107

Contact: Evelyn Lechner, MD +43505546324706
Contact: Hans Gombotz, MD, PHD +4373278062157

Children´s Heart Center Linz Recruiting
Linz, Austria, 4020
Contact: Evelyn Lechner, MD   
Contact: Anna Hofer, MD       anna.hofer@akh.linzat   
Principal Investigator: Evelyn Lechner, MD         
Principal Investigator: Anna Hofer, MD         
Sponsors and Collaborators
Ludwig Boltzmann Gesellschaft
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

Publications: Identifier: NCT00549107     History of Changes
Other Study ID Numbers: 1-365
First Posted: October 25, 2007    Key Record Dates
Last Update Posted: October 25, 2007
Last Verified: October 2007

Keywords provided by Ludwig Boltzmann Gesellschaft:
low cardiac output syndrome
open heart surgery
Low cardiac output syndrome in infants undergoing corrective open heart surgery

Additional relevant MeSH terms:
Cardiac Output, Low
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Phosphodiesterase 3 Inhibitors