Table 2 Data collection during the trial

Screening and 24-h period before randomization:

 • Basic data (sex, age, weight, height, time of hospital admission, time of ICU admission, type of admission, referring facility prior to transfer to the ICU), onset of septic shock, primary or secondary admission diagnoses, and concomitant diseases

 • Data on infection, microbiology, anti-infective therapy, and raw data for the calculation of APACHE II, SAPS II, and SOFA scores

 • Assessment of concomitant medication (catecholamines, inotropes, diuretics, fluid therapy including transfusion, adjunctive sepsis therapy)

 • Intensive care interventions (intubation, central venous catheter, arterial catheter, renal replacement therapy, ventilation, extracorporeal membrane oxygenation, haemodynamic monitoring)

 • Clinical parameters (body temperature, respiratory frequency, haemodynamic parameters (systolic arterial pressure, mean arterial pressure, diastolic arterial pressure, central venous pressure, cardiac output))

Time of randomization:

 • Data on infection, microbiology, anti-infective therapy, clinical parameters, and concomitant medication

 • Routine data from the laboratory, performed in the 24-h period before randomization: haemoglobin, creatinine, bilirubin, C-reactive protein, procalcitonin, leucocytes, platelets, lactate, arterial blood gas analysis, and intensive care interventions

 • AEs, SAEs, sepsis-related clinical events

Time period until 2 h after randomization:

 • Data on infection, microbiology, and anti-infective therapy

 • AEs, SAEs, and sepsis-related clinical events

 • Data on trial drug administration

Trial visit at 6 h after randomization:

 • Data on infection, microbiology, anti-infective therapy, and co-medication with catecholamines and inotropes

 • Concomitant medication with diuretics, fluid therapy including transfusion, adjunctive sepsis therapy, and clinical parameters

 • Routine laboratory data (haemoglobin, lactate, arterial blood gases) and intensive care interventions

 • Capturing of AEs/SAEs, sepsis-related clinical events and recording vital status (alive/dead)

 • Data about administration of the trial drug

Trial visits on trial days 1 to 28 after randomization:

 • Blood sampling to determine the serum albumin concentration

 • Data on infection, microbiology, anti-infective therapy, and raw data for calculation of the SOFA score on the respective study day; the “worst” daily value should be recorded

 • Concomitant medication, intensive care interventions, and the amount of enteral and parenteral fluid adminstration

 • Routine laboratory data and clinical parameters, 24 h urinary output, other fluid loss

 • AEs/SAEs, sepsis-related clinical events, and vital status (live/dead)

 • Data on administration of the trial drug

Data are collected from participants at one of the following time points, whichever comes first: Discharge from the hospital before or on trial day 28, discharge from the hospital up to and including trial day 90, trial day 90 reached in the hospital (regular end of study), early termination of the clinical trial. These data include:

 • Ongoing SAEs and serious sepsis-related clinical events

 • Vital status (alive/dead): if applicable, date of death and cause of death; if applicable, recording of “end of life” decisions, stay after discharge

 • ICU length of stay (of the first ICU stay after study participation)

 • Hospital length of stay (first hospital stay after study participation)

 • If the patient is discharged from the ICU or the hospital during the 90-day observation period, this time is defined as the endpoint for determining the ICU length of stay and/or hospital stay. If the patient returns to the ICU or hospital within the 90 days, this is no longer relevant for the collection of trial endpoints.

Data collection at trial days 28, 60, and 90 after randomization:

 • Vital status (alive/dead): if applicable, date of death and cause of death; if applicable, recording of “end of life” decisions, stay after discharge

 • Verification of the documentation of SAEs already detected and serious sepsis-related clinical events, possibly AEs, which are “ongoing” at the respective time point