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

October 24, 2007 updated by: Ludwig Boltzmann Gesellschaft

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4020
        • Recruiting
        • Children´s Heart Center Linz
        • Contact:
        • Contact:
        • Principal Investigator:
          • Evelyn Lechner, MD
        • Principal Investigator:
          • Anna Hofer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Levosimendan
Active Comparator: 2
Drug: Milrinone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac output measured by a transesophageal probe
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in mixed venous saturation
Time Frame: 48 hours
48 hours
Serum lactate levels
Time Frame: 48 hours
48 hours
Cardiac output and ventricular function assessed by echocardiography
Time Frame: 48 hours
48 hours
Mean arterial, left atrial and central venous pressure
Time Frame: 48 hours
48 hours
Need of catecholamines assessed with the inotropic score
Time Frame: 48 hours
48 hours
Urine output
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Study Registration Dates

First Submitted

October 24, 2007

First Submitted That Met QC Criteria

October 24, 2007

First Posted (Estimate)

October 25, 2007

Study Record Updates

Last Update Posted (Estimate)

October 25, 2007

Last Update Submitted That Met QC Criteria

October 24, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-365

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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