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

NCT ID: NCT01301313

Last Updated: 2013-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Heart Failure

Keywords

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Acute heart failure Children Levosimendan Inotropic treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Levosimendan

Group Type EXPERIMENTAL

Levosimendan

Intervention Type DRUG

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.

Conventional intensified inotropic treatment

Group Type ACTIVE_COMPARATOR

Conventional intensified inotropic treatment

Intervention Type DRUG

Increasing the dose and / or the number of inotropes (dopamine and / or dobutamine and / or milrinone and / or adrenaline)

Interventions

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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.

Intervention Type DRUG

Conventional intensified inotropic treatment

Increasing the dose and / or the number of inotropes (dopamine and / or dobutamine and / or milrinone and / or adrenaline)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

24 Hours

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jose Luis Vazquez Martinez

OTHER

Sponsor Role lead

Responsible Party

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Jose Luis Vazquez Martinez

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jose Luis Vazquez MArtinez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramón y Cajal. Madrid

Locations

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Hospital Clínico Universitario de Santiago de Compostela

A Coruña, A Coruña, Spain

Site Status

Hospital Juan Canalejo

A Coruña, A Coruña, Spain

Site Status

Hospital San Joan de Deu

Barcelona, Barcelona, Spain

Site Status

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

Site Status

Hospital Universitario Ramon y Cajal

Madrid, Madrid, Spain

Site Status

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Site Status

Hospital Infantil La Paz

Madrid, Madrid, Spain

Site Status

Hospital Universitario Doce de Octubre

Madrid, Madrid, Spain

Site Status

Hospital Universitario Carlos Haya

Málaga, Malaga, Spain

Site Status

Hospital Virgen de la Arrixaca

Murcia, Murcia, Spain

Site Status

Hospital Clínico Universitario Son Dureta

Palma de Mallorca, Palma de Mallorca, Spain

Site Status

Complejo Hospitalario Universitario de Salamanca

Salamanca, Salamanca, Spain

Site Status

Hospital Donosti

Donostia / San Sebastian, San Sebastian, Spain

Site Status

Hospital Virgen de la Salud

Toledo, Toledo, Spain

Site Status

Hospital Clínico de Valencia

Valencia, Valencia, Spain

Site Status

Hospital La Fe

Valencia, Valencia, Spain

Site Status

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, Spain

Site Status

Hospital de Cruces

Vizcaya, Vizcaya, Spain

Site Status

Hospital Miguel Servet

Zaragoza, Zaragoza, Spain

Site Status

Countries

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Spain

Other Identifiers

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2009-017827-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LEVOPED1

Identifier Type: -

Identifier Source: org_study_id