Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children
Primary Purpose
Acute Heart Failure
Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Levosimendan
Conventional intensified inotropic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Acute Heart Failure focused on measuring Acute heart failure, Children, Levosimendan, Inotropic treatment
Eligibility 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
Sites / Locations
- Hospital Donosti
- Hospital Clínico Universitario de Santiago de Compostela
- Hospital Juan Canalejo
- Hospital San Joan de Deu
- Hospital Universitario Reina Sofía
- Hospital Universitario Ramon y Cajal
- Hospital General Universitario Gregorio Marañón
- Hospital Infantil La Paz
- Hospital Universitario Doce de Octubre
- Hospital Universitario Carlos Haya
- Hospital Virgen de la Arrixaca
- Hospital Clínico Universitario Son Dureta
- Complejo Hospitalario Universitario de Salamanca
- Hospital Virgen de la Salud
- Hospital Clínico de Valencia
- Hospital La Fe
- Hospital Clínico Universitario de Valladolid
- Hospital de Cruces
- Hospital Miguel Servet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Levosimendan
Conventional intensified inotropic treatment
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
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.
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.
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.
Survival
Survival, at 30 days
Full Information
NCT ID
NCT01301313
First Posted
February 22, 2011
Last Updated
January 30, 2013
Sponsor
Jose Luis Vazquez Martinez
1. Study Identification
Unique Protocol Identification Number
NCT01301313
Brief Title
Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children
Official Title
Phase II Study to Evaluate the Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jose Luis Vazquez Martinez
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure
Keywords
Acute heart failure, Children, Levosimendan, Inotropic treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levosimendan
Arm Type
Experimental
Arm Title
Conventional intensified inotropic treatment
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Levosimendan
Intervention Description
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
Intervention Name(s)
Conventional intensified inotropic treatment
Intervention Description
Increasing the dose and / or the number of inotropes (dopamine and / or dobutamine and / or milrinone and / or adrenaline)
Primary Outcome Measure Information:
Title
Hemodynamic improvement at 24 hours
Description
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 Outcome Measure Information:
Title
Improvement in cardiac output
Description
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
Title
Improvement in the neurohormonal profile
Description
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
Title
Number of days of hospital stay in paediatric intensive care unit
Description
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
Title
Safety
Description
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
Title
Survival
Description
Survival, at 30 days
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Hours
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Luis Vazquez MArtinez, MD
Organizational Affiliation
Hospital Universitario Ramón y Cajal. Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Donosti
City
Donostia
State/Province
San Sebastian
Country
Spain
Facility Name
Hospital Clínico Universitario de Santiago de Compostela
City
A Coruña
Country
Spain
Facility Name
Hospital Juan Canalejo
City
A Coruña
Country
Spain
Facility Name
Hospital San Joan de Deu
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
Country
Spain
Facility Name
Hospital Infantil La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Doce de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Carlos Haya
City
Malaga
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Hospital Clínico Universitario Son Dureta
City
Palma de Mallorca
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Virgen de la Salud
City
Toledo
Country
Spain
Facility Name
Hospital Clínico de Valencia
City
Valencia
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
Country
Spain
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
Country
Spain
Facility Name
Hospital de Cruces
City
Vizcaya
Country
Spain
Facility Name
Hospital Miguel Servet
City
Zaragoza
Country
Spain
12. IPD Sharing Statement
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Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children
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