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

NCT00549107 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2007-10-25

No results posted yet for this study

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

Interventions

DRUG

Levosimendan

DRUG

Milrinone

Sponsors & Collaborators

  • Ludwig Boltzmann Gesellschaft

    lead OTHER

Principal Investigators

  • Evelyn Lechner, MD · Children´s Heart Center Linz

  • Hans Gombotz, MD, PHD · General Hospital Linz, Ludwig Boltzmann Gesellschaft

  • Anna Hofer, MD · General Hospital Linz

  • Gerald Tulzer, MD, PHD · Children´s Heart Center Linz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00549107 on ClinicalTrials.gov