after joining the study, you are assigned by the study staff to receive either the test medication elaspol (which contains sivelestat) or the placebo solution sodium chloride.

the assignment is done randomly, so you do not know which one you will receive.

the assigned medication is given by intravenous (iv) infusion, which means it is delivered directly into a vein.

if you receive elaspol, the dose is 0.2 mg/kg/h (milligrams per kilogram of body weight per hour) of sivelestat, mixed into a solution and infused continuously.

if you receive the placebo, the infusion contains 50 ml of a sodium chloride solution.

the infusion is started on day 1 and continues for at least 24 hours, with the exact duration determined by the study protocol.

blood samples are taken before the first infusion (day 1 baseline) and then on day 2, day 3, day 4, and day 7.

the tests include measurements of coagulation and fibrinolysis markers such as plasma plasminogen, pt, d‑dimer, antithrombin, and others, as well as a complete blood count (cbc).

these results are used to evaluate the effect of the medication on your blood‑clotting system.

throughout the infusion period and the hospital stay, study staff systematically record any adverse events (ae), which are any unwanted medical occurrences.

serious adverse events (sae), especially bleeding or clotting problems, are given special attention.

your vital signs and organ‑function indicators are checked regularly.

additional clinical evaluations are performed up to day 28, including the sepsis support index (ssi), a penalized ssi, and the sofa score, which measures the severity of organ failure.

the sofa score is recorded on day 1, day 2, day 3, day 4, and day 7.

the study continues to collect information on your status up to day 90.

outcomes recorded include the number of days free from mechanical ventilation, vasopressor support, intensive care unit (icu) stay, and overall hospitalization.

mortality (whether you are alive) is noted at day 7, day 28, and day 90.