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The Results of the Classic Trial of Septic Shock Patients in Europe
Our primary outcome was 90-day all course mortality and then we had a number of secondary outcomes which were serious adverse events in the ICU. We estimated that 1,554 patients were to be enrolled to gain 80% power to detect an absolute difference in 90-day mortality of 7 percentage points. The classic data and safety monitoring committee composed of Professor Willid Al-Hassani, Dr. Fernando Sampieri and Senior Scientist Liz Starkhoof recommended to continue the trial.