Fig. 2.

Schedule of the trial visits and study procedures. ¹After obtaining informed consent. ²Basic data: sex, age, weight, height, time of hospital admission, time of intensive care unit (ICU) admission, type of admission, referring facility prior to ICU admission, etc. from the 24-h period before randomization (data from ICU or normal ward). ³Albumin group: determination of serum albumin concentration before administration of the starting dose of the trial drug. ⁴Body temperature, respiratory rate, and haemodynamic parameters. ⁵Catecholamines, inotropic agents, diuretics, volume replacement therapy, including blood transfusion, adjunctive sepsis therapy. ⁶Recording of concomitant medication with catecholamines and inotropes at the corresponding time point (+/− 1 h); recording of concomitant medication with diuretics, volume therapeutics including transfusion therapy, adjunctive sepsis therapy of the previous 6 h. ⁷Haemoglobin, creatinine, bilirubin, C-reactive protein, procalcitonin, leucocytes, platelets, lactate, arterial blood gas analysis. ⁸24-h time period prior to randomization. ⁹Procedures, mechanical ventilation, haemodynamic monitoring. ¹⁰If adverse events (AEs) or serious adverse events (SAEs) are still “ongoing” after the end of treatment with the trial drug, observation will continue until the end of data collection (day 90). ¹¹Data on the vital status (alive/dead), if applicable date of death and cause of death, residence after discharge, if applicable, recording of “End of Life” decisions