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

Phase 2TerminatedNCT01301313

Jose Luis Vazquez Martinez116 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

116

Conditions

Acute Heart Failure

Interventions

LevosimendanDRUG

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 treatmentDRUG

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

Eligibility

Sex: ALLMin age: 24 HoursMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Hospital Clínico Universitario de Santiago de Compostela

A Coruña, A Coruña, Spain

Hospital Juan Canalejo

A Coruña, A Coruña, Spain

Outcomes

Primary Outcomes

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)

Time frame: 24 hours

Secondary Outcomes

Improvement in cardiac output

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

Time frame: 24 and 48 hours

Improvement in the neurohormonal profile

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.

Time frame: 24 and 48 hours

Number of days of hospital stay in paediatric intensive care unit

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.

Time frame: 30 days

Safety

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.

Time frame: 30 days

Survival

Survival, at 30 days

Time frame: 30 days

Data from ClinicalTrials.gov

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