NCT01301313

Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children

Phase II Study to Evaluate the Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Jose Luis Vazquez Martinez · Academic / Other
• Sex: All
• Age: 24 Hours – 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of levosimendan versus conventional intensified inotropic treatment, in critical children with severe acute heart failure which persists despite of having received conventional inotropic treatment.

Conditions

• Acute Heart Failure

Interventions

Type	Name	Description
DRUG	Levosimendan	Levosimendan 2.5 mg / ml ampoules. The drug will be administrated in continuous intravenous perfusion in a single dose of 0.1 - 0.2 micrograms/ kg / min for 24 hours.
DRUG	Conventional intensified inotropic treatment	Increasing the dose and / or the number of inotropes (dopamine and / or dobutamine and / or milrinone and / or adrenaline)

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2011-02-23
• Last updated: 2013-01-31

Locations

19 sites across 1 country: Spain