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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Jose Luis Vazquez Martinez, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT01301313
First received: February 22, 2011
Last updated: January 30, 2013
Last verified: January 2013
History of Changes

February 22, 2011
January 30, 2013
February 2011
February 2012   (final data collection date for primary outcome measure)
Hemodynamic improvement at 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
To evaluate the efficacy of levosimendan in the treatment of severe acute heart failure in children in critical conditions comparing the proportion of patients with hemodynamic improvement at 24 hours between the group who received levosimendan as rescue therapy (experimental treatment) versus the one who received intensified conventional inotropic treatment (control treatment)
Same as current
Complete list of historical versions of study NCT01301313 on ClinicalTrials.gov Archive Site
  • Improvement in cardiac output [ Time Frame: 24 and 48 hours ] [ Designated as safety issue: No ]
    To compare the improvement in cardiac output induced by levosimendan in the treatment of severe acute heart failure in critical children versus the intensified conventional inotropic treatment, at 24 and 48h
  • Improvement in the neurohormonal profile [ Time Frame: 24 and 48 hours ] [ Designated as safety issue: No ]
    To compare the improvement in the neurohormonal profile (assessed as a reduction of BNP) induced by levosimendan in the treatment of severe acute heart failure in critical children versus the intensified conventional inotropic treatment, at 24 and 48h.
  • Number of days of hospital stay in paediatric intensive care unit [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    To compare the number of days of hospital stay in paediatric intensive care unit and the number of days on mechanical ventilation, at 30 days.
  • Safety [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    To assess the safety of the use of levosimendan in the treatment of severe acute heart failure in children in critical conditions, at 30 days.
  • Survival [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Survival, at 30 days
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Acute Heart Failure
  • 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)
  • Experimental: Levosimendan
    Intervention: Drug: Levosimendan
  • Active Comparator: Conventional intensified inotropic treatment
    Intervention: Drug: Conventional intensified inotropic treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
116
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who give written consent to participate in the study and for the transfer of material for cellular and molecular studies.
  • Understand the purpose of the study and to be available to perform the procedures written in the protocol.
  • Any child of 1 day old to 18 years old, admitted to the Paediatric Intensive Care Unit due to severe acute heart failure of any etiology.

Exclusion Criteria:

All patients who

  • express their wish of not to participate in the protocol
  • have hypertrophic or restrictive cardiomyopathy
  • have aortic Stenosis
  • have a known allergy to any drug used in the study
  • it is not possible to prescribe the study medication because it is contraindicated according to the Summary of the Product Characteristic or according to the criteria of the physician responsible for patient
  • are pregnant
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01301313
LEVOPED1, 2009-017827-24
Yes
Jose Luis Vazquez Martinez, Hospital Universitario Ramon y Cajal
Jose Luis Vazquez Martinez
Not Provided
Principal Investigator: Jose Luis Vazquez MArtinez, MD Hospital Universitario Ramón y Cajal. Madrid
Hospital Universitario Ramon y Cajal
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP