E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
adult patients with coronary artery disease and/or valvular disease requiring cardiac surgery with the use of cardiopulmonary bypass. |
pacientes adultos de alto riesgo sometidos a cirugía cardiaca con circulación extracorpórea (CEC). |
|
E.1.1.1 | Medical condition in easily understood language |
adult patients with heart disease needing open-heart surgery with the use of heart-lung machine |
pacientes adultos de alto riesgo sometidos a cirugía cardiaca con circulación extracorpórea (CEC). |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective: The primary objective of this study is to evaluate if methylprednisolone given before cardiopulmonary bypass reduces 30-day all-cause mortality in high-risk patients. |
El objetivo principal de este estudio es evaluar si metilprednisolona administrada antes de la circulación extracorpórea reduce la mortalidad por cualquier causa a los 30 días en pacientes de alto riesgo. |
|
E.2.2 | Secondary objectives of the trial |
Most Important Secondary Objective: 1. To evaluate if methylprednisolone given before cardiopulmonary bypass reduces 30-day all-cause mortality or significant myocardial injury in high-risk patients Secondary Objectives 2. To evaluate if methylprednisolone given before cardiopulmonary bypass reduces 6-month all-cause mortality in high-risk patients 3. To evaluate if methylprednisolone given before cardiopulmonary bypass reduces postoperative morbidity related to atrial fibrillation, bleeding, delirium, blood transfusions, and length of stay in high-risk patients 4. To evaluate the safety of methylprednisolone. Assessment of the impact on infections, gastrointestinal, and wound complications. |
1. Evaluar si metilprednisolona administrada antes de la circulación extracorpórea disminuye la mortalidad por cualquier causa a los 30 días o el daño miocárdico significativo en pacientes de alto riesgo. 2. Evaluar si metilprednisolona administrada antes de la circulación extracorpórea reduce la mortalidad por cualquier causa a los 6 meses en pacientes de alto riesgo.
3 Evaluar si metilprednisolona administrada antes de la circulación extracorpórea reduce la morbilidad perioperatoria asociada a fibrilación auricular, sangrado, delirio, transfusiones sanguíneas y duración de la hospitalización en pacientes de alto riesgo.
4 Evaluar la seguridad de metilprednisolona. Evaluación del impacto sobre la tasa de infecciones, complicaciones gastrointestinales y de la herida quirúrgica. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age more or equal to 18 years 2. Require CPB for any cardiac surgical procedure (such as CABG, Valve, Aorta, or combined procedures) 3. EuroScore greater than or equal to 6 4. Written informed consent |
1) Edad ? 18 años 2) CEC para cualquier procedimiento quirúrgico cardíaco 3) Puntuación global del Euroscore ? 6 4) Consentimiento informado |
|
E.4 | Principal exclusion criteria |
1. Use of systemic steroids or will undergo planned systemic steroid therapy in the immediate postoperative period (e.g. cardiac transplantation) 2. History of bacterial or fungal infection in the last 30 days 3. Allergy or intolerance to corticosteroids 4. Receiving Aprotinin 5. Previous participation in this study |
1) Uso de esteroides sistémicos o pacientes que necesitarán corticoides sistémicos en el periodo postoperatorio inmediato (ej: transplante cardíaco) 2) Antecedentes de infección bacteriana o fúngica en los últimos 30 días 3) Alergia o intolerancia a los corticosteroides 4) En tratamiento con Aprotinina 5) Participación previa en el estudio |
|
E.5 End points |
E.5.1 | Primary end point(s) |
30-Day post-surgery all-cause mortality |
Mortalidad por cualquier causa a los 30 días. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary end point, all-cause mortality, will be evaluated 30 days after surgery. |
Incidencia de muerte por cualquier causa o daño miocárdico mayor a los 30 días. |
|
E.5.2 | Secondary end point(s) |
The incidence of a composite of significant myocardial injury or death at 30 days is the most important secondary end point. All-cause mortality at 6 months, new onset atrial fibrillation, transfusion requirements, bleeding (chest tube output 24 hour), duration of mechanical ventilation, length of ICU stay and hospital stay. Infection, delirium, stroke, wound complication, GI hemorrhage, GI perforation, postoperative insulin use and peak blood glucose during the first 24 hours after surgery. |
Resultado Secundario más importante Incidencia de muerte por cualquier causa o daño miocárdico mayor a los 30 días. Otros resultados de eficacia: Mortalidad por cualquier causa a los 6 meses, nuevo episodio de fibrilación auricular, transfusiones sanguíneas, sangrado (drenaje torácico a las 24 horas), duración de la ventilación mecánica, duración del ingreso en UCI y duración de la hospitalización.
Resultados de Seguridad Infección, delirio, accidente vascular, complicaciones de la herida, hemorragia gastrointestinal, perforación gastrointestinal, uso de insulina en el postoperatorio y glicemia máxima en las primeras 24 horas postoperatorias. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The most important secondary end point will be evaluated 30 days after surgery. Other efficacy and safety end points will be evaluated at all visits after surgery (at the ICU visit (i.e. 24 hours post-operatively), at the discharge visit, at the 30-day and 6-month follow up visits). |
Resultado Secundario más importante Incidencia de muerte por cualquier causa o daño miocárdico mayor a los 30 días. Eficacia y seguridad End points, serán evaluados despues de la operación (en la visita a las 24 horas (UCI), en la vista a los 30 días y en la visita de seguimiento a los 6 meses. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Austria |
Belgium |
Brazil |
Canada |
Chile |
China |
Colombia |
Czech Republic |
Greece |
Hungary |
India |
Iran, Islamic Republic of |
Ireland |
Italy |
South Africa |
Spain |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
El investigador y/o el paciente podrán decidir la salida prematura del estudio si lo creen conveniente. En este caso el paciente será tratado seguiendo la práctica habitual de su patologia |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |