Acute Heart Failure
Conditions
Keywords
Acute heart failure, Children, Levosimendan, Inotropic 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.
Interventions
DRUGLevosimendan
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.
DRUGConventional intensified inotropic treatment
Increasing the dose and / or the number of inotropes (dopamine and / or dobutamine and / or milrinone and / or adrenaline)
Sponsors
Jose Luis Vazquez Martinez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
24 Hours to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic improvement at 24 hours | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in cardiac output | 24 and 48 hours | 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 | 24 and 48 hours | 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 | 30 days | 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 | 30 days | 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 | 30 days | Survival, at 30 days |
Countries
Spain
Outcome results
None listed