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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Ludwig Boltzmann Gesellschaft.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00549107
First Posted: October 25, 2007
Last Update Posted: October 25, 2007
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.
Information provided by:
Ludwig Boltzmann Gesellschaft
  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 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


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
Experimental: 1 Drug: Levosimendan
Active Comparator: 2 Drug: Milrinone

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00549107     History of Changes
Other Study ID Numbers: 1-365
First Submitted: October 24, 2007
First Posted: October 25, 2007
Last Update Posted: October 25, 2007
Last Verified: October 2007

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

Additional relevant MeSH terms:
Syndrome
Cardiac Output, Low
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Simendan
Milrinone
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


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