Event | Presentation until start of iloprost or NaCl 0.9% | d1 | d2 | d3 | d4 | d5 | d6–d27 | Hospital discharge or d28 | Hospital discharge or d90 | d180 ± 14d |
---|---|---|---|---|---|---|---|---|---|---|
Informed consent | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Inclusion/exclusion criteria | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Pregnancy test in women of childbearing age | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Demographics | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Medical history | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Randomization | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Iloprost or NaCl 0.9% (control) | Â | X | X | X | X | X | Â | Â | Â | Â |
Clinical assessment including outcome | X | X | X | X | X | X | X | X | X | Â |
Laboratory testing | X | X | X | X | X | X | X | X | Â | Â |
Adverse/serious adverse event monitoring | Â | X | X | X | X | X | X | X | Â | Â |
Plasma biomarkers | X | X | X | X | X | X | Â | Â | Â | Â |
Barthel Index | X | Â | Â | Â | Â | Â | Â | X | X | X |
SOFA score | X | X | X | X | X | X | X | X | Â | Â |
Health-related questionnaire | Â | Â | Â | Â | Â | Â | Â | Â | Â | X |
VES | Â | Â | Â | Â | Â | Â | Â | Â | Â | X |