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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017827-24 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levosimendan | Experimental |
| |
| Conventional intensified inotropic treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levosimendan | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 and 48 hours |
| Improvement in the neurohormonal profile |
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Inclusion Criteria:
Exclusion Criteria:
All patients who
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| Name | Affiliation | Role |
|---|---|---|
| Jose Luis Vazquez MArtinez, MD | Hospital Universitario Ramón y Cajal. Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario de Santiago de Compostela | A Coruña | A Coruña | Spain | |||
| Hospital Juan Canalejo |
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| Conventional intensified inotropic treatment | Drug | Increasing the dose and / or the number of inotropes (dopamine and / or dobutamine and / or milrinone and / or adrenaline) |
|
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. |
| 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. | 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. | 30 days |
| Survival | Survival, at 30 days | 30 days |
| 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 |
| ID | Term |
|---|---|
| D000077464 | Simendan |
| ID | Term |
|---|---|
| D006835 | Hydrazones |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D011724 | Pyridazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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