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OpenTrials
Completed

NCT Number: NCT00695929

Levosimendan in Congenital Cardiac Surgery

Many pediatric patients undergoing cardiac surgery under cardiopulmonary bypass for repair of complex congenital malformations, require inotropic support for low cardiac output syndrome. Milrinone through its positive inotropic and vasodilatory effects is widely used for this purpose. The aim of the study is to compare Milrinone with Levosimendan, a novel inotope with calcium-sensitizing properties. We hypothesized that using Levosimendan would result in reduced serum lactate through a higher cardiac index.

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Key information

Conditions

Congenital Cardiovascular Defects Cardiac Output, Low Cardiovascular Diseases Heart Diseases Low Cardiac Output Syndrome Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 day–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients undergoing complex cardiac surgery under cardiopulmonary bypass and requiring inotropic support

Exclusion criteria

  • Patients with renal and/or hepatic dysfunction
  • Patients requiring inotropic support before their surgery
  • Septic patients

Treatment and study plan

Levosimendan

Drug

Intravenous injection

Milrinone

Drug

Intravenous injection

Primary outcomes

  1. serum lactate

    Time frame: 12 h postoperatively

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 12, 2008
Registry last updated
Jan 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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