E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cardiac surgery-associated acute kidney injury |
Fracaso renal agudo asociado a cirugía cardiaca |
|
E.1.1.1 | Medical condition in easily understood language |
Renal injury due to cardiac surgery |
Lesión renal asociada a cirugía cardiaca |
|
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 |
To evaluate the efficacy of 10 mg empagliflozin in preventing acute kidney injury stage 1 or higher in cardiac surgery patients |
Evaluar la eficacia de empagliflozina 10 mg en la prevención del fracaso renal agudo estadio 1 o más grave en pacientes de cirugía cardiaca |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of 10 mg empagliflozin in preventing perioperative mortality in cardiac surgery patients
To evaluate the efficacy of 10 mg empagliflozin in reducing the overall perioperative length of stay in cardiac surgery patients |
Evaluar la eficacia de empagliflozina 10 mg en la prevención de mortalidad perioperatoria en pacientes de cirugía cardiaca.
Evaluar la eficacia de empagliflozina 10 mg en la reducción de la estancia hospitalaria perioperatoria en pacientes de cirugía cardiaca. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age ≥18 years. Indication of programmed cardiac surgery with cardio-pulmonary bypass Patient must be able to understand the objectives of the trial and to provide written informed consent |
Edad ≥18 años Indicación de cirugía cardiaca programada con uso de bypass cardiopulmonar Paciente capaz de comprender los objetivos del estudio y de otorgar consentimiento informado por escrito |
|
E.4 | Principal exclusion criteria |
Surgical emergencies Subjects with endocarditis Subjects with unstable angina Patients awaiting heart transplantation. Projected use of intra-aortic balloon pump Chronic kidney disease, defined as an estimated glomerular filtration rate ≤30 ml/min/1.73m2. Severe liver dysfunction, defined as ALT or AST> 3 times the upper limit of normality Patients with active neoplasms Patients in active treatment with any iSGLT2 Known allergy to empagliflozin, any other iSGLT2 or any of its excipients. Solid organ transplant recipients Pregnant or lactating women Subjects who paticipated in another clinical trial in the six months prior to study enrollment |
Urgencias quirúrgicas Pacientes con angina inestable Pacientes en lista de espera de trasplante cardiaco Uso previsto de balón de contrapulsación Enfermedad renal crónica, definida por una tasa estimada de filtrado glomerular ≤30 ml/min/1.73m2. Enfermedad hepática severa, definida por una ALT o AST > 3 veces el límite superior de normalidad Neoplasia activa Pacientes en tratamiento activo con cualquier iSGLT2 Alergia conocida a cualquier iSGLT2 o sus excipientes Receptores de trasplante de órgano sólido Mujeres embarazadas o lactantes Pacientes que hayan participado en otro ensayo clínico en los seis meses anteriores a la fecha de reclutamiento |
|
E.5 End points |
E.5.1 | Primary end point(s) |
30% reduction in the incidence of postoperative acute kidney injury, defined according to the KDIGO Clinical Practice Guidelines as any of the following: Increase in serum creatinine by 0.3 mg/dl within 48 hours Increase in serum creatinine to 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days Urine volume of 0.5 ml/kg/h for 6 hours. |
Reducción del 30% en la incidencia de fracaso renal agudo postoperatorio, definido según las guías KDIGO y de acuerdo a los siguientes criterios: Aumento de la creatinina sérica en 0.3 mg/dl en un periodo de 48 horas Aumento en la creatinina sérica en 1.5 veces los valores basales y que se haya producido en los últimos 7 días Diuresis de 0.5 ml/kg/h durante un periodo de 6 horas. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Proportion of patients who presented a composite event of acute kidney injury stage 3 or death during admission
Proportion of patients who died during admission
Proportion of patients who required renal replacement therapy during admission
Proportion of patients with postoperative complications, defined as low cardiac output, need for reoperation, delirium, seizures, surgical site infection, sepsis, arrhythmia, cardiac arrest, vasoplegia, pneumonia, liver dysfunction or need for blood transfusion
Total time on mechanical ventilation
Total time of ICU stay
Total time of in-hospital stay |
Proporción de pacientes que sufrieron un evento compuesto de fracaso renal agudo estadio 3 o muerte durante el ingreso
Proporción de pacientes que fallecieron durante el ingreso
Proporción de pacientes que precisaron terapia renal sustitutiva durante el ingreso
Proporción de pacientes con complicaciones postoperatorias, definidas como bajo gasto cardiaco, necesidad de reintervención, delirium, convulsiones, infección de la herida quirúrgica, sepsis, arritmias, parada cardiaca, vasoplegia, neumonía, disfunción hepática o necesidad de transfusión sanguínea
Total time on mechanical ventilation
Total time of ICU stay
Total time of in-hospital stay |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
28 days, death or hospital discharge |
28 días, fallecimiento o alta hospitalaria |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
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 | Yes |
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
| 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 | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |