Table 2:
Primary, secondary, tertiary and safety endpoint of the VERTIGO trial.
| Primary endpoint |
|---|
| Proportion of patients that present MAKE90, defined as one or more of the following: |
| - ≥25% eGFR decline from preoperative baseline |
| - Start of renal replacement therapy |
| - Patient death |
| Secondary endpoints |
| - Proportion of participants who developed any stage of AKI defined according to KDIGO guidelines during index admission |
| - Proportion of patients who suffered a Stage 3 AKI according to KDIGO guidelines during index admission |
| - Proportion of patients who required renal replacement therapy during index admission |
| - Proportion of patients who died during index admission |
| - Proportion of patients that maintain ≥25% eGFR decline from preoperative baseline 90 days after surgery |
| Tertiary endpoints |
| - Difference in total time (h) on mechanical ventilation |
| - Difference in mean daily dose of inotropes used |
| - Difference in plasma levels of interleukin-6 and C-reactive protein |
| - Difference in urinary levels of interleukin-18 and protein/creatinine ratio |
| - Difference in serum interleukin-1β and interleukin-18 concentration |
| - Time to first occurrence of postoperative complications, defined as low cardiac output, reoperation for bleeding, delirium, seizures, surgical site infection, sepsis, arrhythmias, cardiac arrest, pneumonia, liver dysfunction or need for blood transfusion |
| - Difference in total time (days) spent in the ICU |
| - Difference in total time (days) of index hospital stay |
| - Difference in rates of hospital readmission due to cardiovascular disease |
| - Difference in frailty evaluation, represented by the results of the Clinical Frailty Scale |
| - Patient reported quality of life EuroQoL-5D |
| Safety endpoints |
| - Adverse events |
| - Serious adverse events (i.e. adverse event that results in death, is considered life-threatening, requires or extends an hospitalization episode, causes disability or is judged as such according to the clinical criteria of the research team) |
| - Discontinuation of study medication due to adverse events |
ICU, intensive care unit.