MedTrace Logo

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

NCT01301313 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2013-01-31

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Jose Luis Vazquez Martinez

    lead OTHER

Principal Investigators

  • Jose Luis Vazquez MArtinez, MD · Hospital Universitario Ramón y Cajal. Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
24 Hours
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Spain

Study Locations

More Related Trials

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 NCT01301313 on ClinicalTrials.gov