E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cardiovascular complications after colorectal surgery |
Complicaciones cardiovasculares postoperatorias en cirugía colorectal electiva |
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E.1.1.1 | Medical condition in easily understood language |
Cardiovascular complications after colorectal surgery |
Complicaciones cardiovasculares postoperatorias en cirugía colorectal electiva |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007648 |
E.1.2 | Term | Cardiovascular disease, unspecified |
E.1.2 | System Organ Class | 100000004849 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050322 |
E.1.2 | Term | Oxygen supplementation |
E.1.2 | System Organ Class | 100000004865 |
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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 main objective is to assess if hyperoxia ( intraoperative FiO2 >80%) increases the postoperative incidence of myocardic injury during first 96 hours after surgery |
El objetivo principal del estudio es determinar si la hiperoxia ( FiO2 intraoperatoria >80%) incrementa la incidencia postoperatoria de daño miocardico en las 96h siguientes a la cirugía |
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E.2.2 | Secondary objectives of the trial |
- Cardiovascular complications at 30 days postoperative - Mortality at 30 days postoperative - Cardiovascular complications at 1 year postoperative - Mortality at 1 year postoperative |
- Complicaciones cardiovasculares a los 30 días del postoperatorio - Mortalidad a los 30 días postoperatorio - Complicaciones cardiovasculares al 1 año postoperatorio - Mortalidad a 1 año postoperatorio |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Elective colorectal surgery - Age > 18 year |
- Cirugía colorectal electiva - Mayores de 18 años |
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E.4 | Principal exclusion criteria |
- Pregnancy - severe COPD - Acute cardiovascular syndrom 6 weeks prior surgery - Hemodialysis - General anesthesia administered 1 month prior surgery - The impossibility to sign / to understand the informed consent - Intraoperative complications that requires mechanical ventilation or vasoactive drugs in the postoperative period |
- Embarazo - EPOC severo - Síndrome cardiovascular agudo las 6 semanas previas a la cirugía - Hemodiálisis - Anestesia general recibida 1 mes antes de la cirugía - Imposibilidad para comprender/firmar el consentimiento informado - Complicaciones intraoperatorias que requieren ventilación mecánica o uso de fármacos vasoactivas en el postoperatorio |
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E.5 End points |
E.5.1 | Primary end point(s) |
Myocardial injury, described as: - MINS (myocardial injury after non cardiac surgery) - Acute coronary syndrom ( including acute myocardial infarction, unstable angina and sudden cardiac death) |
Daño miocárdico, descrito como: - MINS (myocardial injury after non cardiac surgery) - Síndrome coronario agudo ( incluye infarto agudo de miocardio, angina inestable y muerte súbita de causa cardiológica) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
96 hours postoperative |
96 horas postoperatorias |
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E.5.2 | Secondary end point(s) |
- New diagnosis of cardiovascular diseases : arrhythmias of new appearance, heart failure, invasive coronary procedure, pulmonary thromboembolism, stroke - Death |
- Enfermedades cardiovasculares de nuevo diagnóstico: arrítmias de nueva aparición, insuficiencia cardíaca, procedimientos coronarios invasivos, tromboembolismo pulmonar, accidente vascular cerebral - Muerte |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
30 days and 1 year postoperative |
30 días y un año postoperatorio |
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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 | No |
E.6.4 | Safety | Yes |
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 | Yes |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
oxígeno a FiO2 80% vs 40% |
oxygen at 80% FiO2 vs 40% FiO2 |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
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The study is expected to begin in the third quarter of 2018, ending in the third quarter of the year 2021 |
Se prevé iniciar el estudio en el tercer trimestre del año 2018, finalizando el tercer trimestre del año 2021 |
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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 | |
E.8.9.1 | In the Member State concerned days | |