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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 because the information has not been verified recently.
Verified October 2007 by Ludwig Boltzmann Gesellschaft.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ludwig Boltzmann Gesellschaft
ClinicalTrials.gov Identifier:
NCT00549107
First received: October 24, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

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:

ClinicalTrials.gov Identifier: NCT00549107     History of Changes
Other Study ID Numbers: 1-365
Study First Received: October 24, 2007
Last Updated: October 24, 2007
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

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

ClinicalTrials.gov processed this record on June 17, 2013