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- Ensayo clínico NCT00821262
Sevoflurane in Cardiac Surgery (SEVO AIFA)
Sevoflurane and Cardiac Protection in High Risk Patients Undergoing Cardiac Surgery. A Randomized Controlled Study.
Patients undergoing high risk cardiac surgery (combined CABG and valvular procedures) will be randomized to receive a total intravenous anesthesia or an anesthesia plan with sevoflurane.
The investigators want to document whether the cardioprotective properties of volatile agents could translate in an improved outcome after cardiac surgery in high risk patients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background
It is commonly believed that the choice of the primary anesthetic agent does not result in different outcomes after cardiac surgery. Recent evidence however has indicated that volatile anesthetics improve post-ischemic recovery. These results have been summarized in a meta-analysis of 22 randomized studies, involving 1922 patients: the use of volatile anesthetics was associated with significant reductions of myocardial infarctions (24/979 [2.4%] in the volatile anesthetics group vs 45/874 [5.1%] in the control arm, odds ratio [OR]=0.51 [0.32-0.84], and mortality (4/977 [0.4%] vs 14/872 [1.6%], OR=0.31 [0.12-0.80].
Furthermore, the use of volatile anesthetics was associated with shorter intensive-care unit stay (WMD=-7.10 hours [-11.47; -2.73], and time to hospital discharge (WMD=-2.26 days [-3.83; -0.68].
All the studies of the meta-analysis included low risk patients undergoing isolated procedures (mostly coronary artery bypass grafting).
Objectives
Investigators are planning a large multicentre randomized controlled study to confirm the beneficial cardioprotective effects of volatile anesthetics in cardiac surgery as indicated by a reduced intensive care stay and/or death in an high risk population of patients undergoing combined valvular and coronary procedures. Secondary endpoints will be: cardiac troponin release; incidence of myocardial infarction; time on mechanical ventilation; postoperative hospital stay
Methods
Various centers will randomize 200 patients to receive either a total intravenous anesthesia with propofol or an anesthesia with sevoflurane. All patients will receive a standard middle dose opiates anesthesia. All the perioperative management will be otherwise identical and standardized. Transfer out of the intensive care will be performed with SpO2 94% or greater at an FiO2 of 0.5 or less by facemask, adequate cardiac stability with no hemodynamically significant arrhythmias, chest tube drainage less than 50 ml/h, urine output greater than 0.5 ml/kg/h, no intravenous inotropic or vasopressor therapy in excess of dopamine 5 ug/kg/min, and no seizure activity.
Expected Results
The reduced cardiac damage (reduction in cardiac troponin release and in the incidence of myocardial infarction) will translate into a better tissue perfusion and faster recovery as documented by reduced intensive care unit.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Milano, Italia
- Vita-Salute University
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Padova, Italia
- Azienda Ospedaliera di Padova
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Perugia, Italia
- Azienda Ospedaliera di Perugia (H Santa Maria della Misericordia)
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Pisa, Italia
- Azienda Ospedaliera Universitaria Pisana
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Roma, Italia
- Università La Sapienza, Policlinico Umberto I, Roma
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- age >18 years
- written informed consent
- scheduled procedures
Exclusion Criteria:
- ongoing acute myocardial infarction
- cardiac troponin >1 ng/ml
- previous unusual response to an anesthetic
- use of sulfonylurea, theophylline or allopurinol
- thoracotomy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: sevoflurane
The study group will receive Sevoflurane for a 4-6 hours period (from anesthesia induction to transfer to ICU).
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Comparador activo: propofol
The control group will receive propofol for the same 4-6 hours period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Composite endpoint or number of dead patients and/or number of patients requiring prolonged intensive care unit stay
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Medidas de resultado secundarias
Medida de resultado |
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tiempo en ventilación mecánica
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cardiac troponin release
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incidence of perioperative myocardial infarction
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postoperative hospital stay
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: giovanni landoni, MD, Vita-Salute University of Milano. Italy
- Director de estudio: elena bignami, MD, Vita-Salute University of Milano, Italy
Publicaciones y enlaces útiles
Publicaciones Generales
- Tritapepe L, Landoni G, Guarracino F, Pompei F, Crivellari M, Maselli D, De Luca M, Fochi O, D'Avolio S, Bignami E, Calabro MG, Zangrillo A. Cardiac protection by volatile anaesthetics: a multicentre randomized controlled study in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass. Eur J Anaesthesiol. 2007 Apr;24(4):323-31. doi: 10.1017/S0265021506001931. Epub 2006 Dec 8.
- Guarracino F, Landoni G, Tritapepe L, Pompei F, Leoni A, Aletti G, Scandroglio AM, Maselli D, De Luca M, Marchetti C, Crescenzi G, Zangrillo A. Myocardial damage prevented by volatile anesthetics: a multicenter randomized controlled study. J Cardiothorac Vasc Anesth. 2006 Aug;20(4):477-83. doi: 10.1053/j.jvca.2006.05.012.
- Landoni G, Zambon M, Zangrillo A. Reducing perioperative myocardial infarction with anesthetic drugs and techniques. Curr Drug Targets. 2009 Sep;10(9):858-62. doi: 10.2174/138945009789108837. Epub 2009 Sep 1.
- Landoni G, Biondi-Zoccai GG, Zangrillo A, Bignami E, D'Avolio S, Marchetti C, Calabro MG, Fochi O, Guarracino F, Tritapepe L, De Hert S, Torri G. Desflurane and sevoflurane in cardiac surgery: a meta-analysis of randomized clinical trials. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):502-11. doi: 10.1053/j.jvca.2007.02.013. Epub 2007 May 7.
- Landoni G, Fochi O, Tritapepe L, Guarracino F, Belloni I, Bignami E, Zangrillo A. Cardiac protection by volatile anesthetics. A review. Minerva Anestesiol. 2009 May;75(5):269-73. Epub 2008 Nov 6.
- Landoni G, Zangrillo A, Fochi O, Maj G, Scandroglio AM, Morelli A, Tritapepe L, Montorfano M, Colombo A. Cardiac protection with volatile anesthetics in stenting procedures. J Cardiothorac Vasc Anesth. 2008 Aug;22(4):543-7. doi: 10.1053/j.jvca.2008.02.020. Epub 2008 May 14.
- Landoni G, Fochi O, Zangrillo A. Cardioprotection by volatile anesthetics in noncardiac surgery? No, not yet at least. J Am Coll Cardiol. 2008 Apr 1;51(13):1321; author reply 1321-2. doi: 10.1016/j.jacc.2007.12.020. No abstract available.
- Landoni G, Calabro MG, Marchetti C, Bignami E, Scandroglio AM, Dedola E, De Luca M, Tritapepe L, Crescenzi G, Zangrillo A. Desflurane versus propofol in patients undergoing mitral valve surgery. J Cardiothorac Vasc Anesth. 2007 Oct;21(5):672-7. doi: 10.1053/j.jvca.2006.11.017. Epub 2007 Feb 22.
- Bignami E, Biondi-Zoccai G, Landoni G, Fochi O, Testa V, Sheiban I, Giunta F, Zangrillo A. Volatile anesthetics reduce mortality in cardiac surgery. J Cardiothorac Vasc Anesth. 2009 Oct;23(5):594-9. doi: 10.1053/j.jvca.2009.01.022. Epub 2009 Mar 19.
- Landoni G, Guarracino F, Cariello C, Franco A, Baldassarri R, Borghi G, Covello RD, Gerli C, Crivellari M, Zangrillo A. Volatile compared with total intravenous anaesthesia in patients undergoing high-risk cardiac surgery: a randomized multicentre study. Br J Anaesth. 2014 Dec;113(6):955-63. doi: 10.1093/bja/aeu290. Epub 2014 Sep 3.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GO/URC/ER/mm 412/DG
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