Clinical trial NCT01301313: Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children
Official title: Phase II Study to Evaluate the Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Heart Failure
Keywords: Acute heart failure
Children
Levosimendan
Inotropic treatment
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 116
Sex: ALL
Minimum age (years): 24
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hemodynamic improvement at 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Improvement in cardiac output
timeFrame: 24 and 48 hours
measure: Improvement in the neurohormonal profile
timeFrame: 24 and 48 hours
measure: Number of days of hospital stay in paediatric intensive care unit
timeFrame: 30 days
measure: Safety
timeFrame: 30 days
measure: Survival
timeFrame: 30 days
Other outcomes:
Locations:
city: Donostia
country: Spain
facility: Hospital Donosti
state: San Sebastian
city: A Coruña
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
city: A Coruña
country: Spain
facility: Hospital Juan Canalejo
city: Barcelona
country: Spain
facility: Hospital San Joan de Deu
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Infantil La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Doce de Octubre
city: Malaga
country: Spain
facility: Hospital Universitario Carlos Haya
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Palma de Mallorca
country: Spain
facility: Hospital Clínico Universitario Son Dureta
city: Salamanca
country: Spain
facility: Complejo Hospitalario Universitario de Salamanca
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Vizcaya
country: Spain
facility: Hospital de Cruces
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Hospital Universitario Ramón y Cajal. Madrid
name: Jose Luis Vazquez MArtinez, MD
role: PRINCIPAL_INVESTIGATOR
References: