Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children
This study has been terminated.
Sponsor:
Jose Luis Vazquez Martinez
Information provided by (Responsible Party):
Jose Luis Vazquez Martinez, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT01301313
First received: February 22, 2011
Last updated: January 30, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Heart Failure |
Drug: Levosimendan Drug: Conventional intensified inotropic treatment |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase II Study to Evaluate the Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children |
Resource links provided by NLM:
Further study details as provided by Hospital Universitario Ramon y Cajal:
Primary Outcome Measures:
- Hemodynamic improvement at 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]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 Outcome Measures:
- Improvement in cardiac output [ Time Frame: 24 and 48 hours ] [ Designated as safety issue: No ]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 [ Time Frame: 24 and 48 hours ] [ Designated as safety issue: No ]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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]Survival, at 30 days
| Enrollment: | 116 |
| Study Start Date: | February 2011 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Levosimendan |
Drug: 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.
|
| Active Comparator: Conventional intensified inotropic treatment |
Drug: Conventional intensified inotropic treatment
Increasing the dose and / or the number of inotropes (dopamine and / or dobutamine and / or milrinone and / or adrenaline)
|
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301313
Locations
| Spain | |
| Hospital Donosti | |
| Donostia, San Sebastian, Spain | |
| Hospital Juan Canalejo | |
| A Coruña, Spain | |
| Hospital Clínico Universitario de Santiago de Compostela | |
| A Coruña, Spain | |
| Hospital San Joan de Deu | |
| Barcelona, Spain | |
| Hospital Universitario Reina Sofía | |
| Córdoba, Spain | |
| Hospital Universitario Doce de Octubre | |
| Madrid, Spain | |
| Hospital Infantil La Paz | |
| Madrid, Spain | |
| Hospital Universitario Ramon y Cajal | |
| Madrid, Spain, 28034 | |
| Hospital General Universitario Gregorio Marañón | |
| Madrid, Spain | |
| Hospital Universitario Carlos Haya | |
| Malaga, Spain | |
| Hospital Virgen de la Arrixaca | |
| Murcia, Spain | |
| Hospital Clínico Universitario Son Dureta | |
| Palma de Mallorca, Spain | |
| Complejo Hospitalario Universitario de Salamanca | |
| Salamanca, Spain | |
| Hospital Virgen de la Salud | |
| Toledo, Spain | |
| Hospital La Fe | |
| Valencia, Spain | |
| Hospital Clínico de Valencia | |
| Valencia, Spain | |
| Hospital Clínico Universitario de Valladolid | |
| Valladolid, Spain | |
| Hospital de Cruces | |
| Vizcaya, Spain | |
| Hospital Miguel Servet | |
| Zaragoza, Spain | |
Sponsors and Collaborators
Jose Luis Vazquez Martinez
Investigators
| Principal Investigator: | Jose Luis Vazquez MArtinez, MD | Hospital Universitario Ramón y Cajal. Madrid |
More Information
No publications provided
| Responsible Party: | Jose Luis Vazquez Martinez, Doctor, Hospital Universitario Ramon y Cajal |
| ClinicalTrials.gov Identifier: | NCT01301313 History of Changes |
| Other Study ID Numbers: | LEVOPED1, 2009-017827-24 |
| Study First Received: | February 22, 2011 |
| Last Updated: | January 30, 2013 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Hospital Universitario Ramon y Cajal:
|
Acute heart failure Children Levosimendan Inotropic treatment |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Simendan Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Cardiotonic Agents Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013