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
2 other identifiers
interventional
116
1 country
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2011
Shorter than P25 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 22, 2011
CompletedFirst Posted
Study publicly available on registry
February 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedJanuary 31, 2013
January 1, 2013
1 year
February 22, 2011
January 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemodynamic improvement at 24 hours
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)
24 hours
Secondary Outcomes (5)
Improvement in cardiac output
24 and 48 hours
Improvement in the neurohormonal profile
24 and 48 hours
Number of days of hospital stay in paediatric intensive care unit
30 days
Safety
30 days
Survival
30 days
Study Arms (2)
Levosimendan
EXPERIMENTALConventional intensified inotropic treatment
ACTIVE COMPARATORInterventions
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.
Increasing the dose and / or the number of inotropes (dopamine and / or dobutamine and / or milrinone and / or adrenaline)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Hospital Clínico Universitario de Santiago de Compostela
A Coruña, A Coruña, Spain
Hospital Juan Canalejo
A Coruña, A Coruña, Spain
Hospital San Joan de Deu
Barcelona, Barcelona, Spain
Hospital Universitario Reina Sofía
Córdoba, Córdoba, Spain
Hospital Universitario Ramon y Cajal
Madrid, Madrid, 28034, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain
Hospital Infantil La Paz
Madrid, Madrid, Spain
Hospital Universitario Doce de Octubre
Madrid, Madrid, Spain
Hospital Universitario Carlos Haya
Málaga, Malaga, Spain
Hospital Virgen de la Arrixaca
Murcia, Murcia, Spain
Hospital Clínico Universitario Son Dureta
Palma de Mallorca, Palma de Mallorca, Spain
Complejo Hospitalario Universitario de Salamanca
Salamanca, Salamanca, Spain
Hospital Donosti
Donostia / San Sebastian, San Sebastian, Spain
Hospital Virgen de la Salud
Toledo, Toledo, Spain
Hospital Clínico de Valencia
Valencia, Valencia, Spain
Hospital La Fe
Valencia, Valencia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, Spain
Hospital de Cruces
Vizcaya, Vizcaya, Spain
Hospital Miguel Servet
Zaragoza, Zaragoza, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Luis Vazquez MArtinez, MD
Hospital Universitario Ramón y Cajal. Madrid
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
February 22, 2011
First Posted
February 23, 2011
Study Start
February 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
January 31, 2013
Record last verified: 2013-01