Visit schedule
| Visit | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7 | Day 8–28 |
|---|---|---|---|---|---|---|---|---|
| Screening | X | |||||||
| Informed consent (patient consent/PerLR/ProLR/retrospective patient information) | Retrospective consent (PerLR/ProLR) will be obtained at the first available opportunity. Retrospective patient consent will be obtained when the patient has recovered | |||||||
| Inclusion/exclusion criteria | X | |||||||
| Randomisation | X | |||||||
| Study drug administration (study drug 1 and 2) | Study drug 1 (vasopressin/noradrenaline) continued until shock resolved. If BP was still low, study drug 2 (hydrocortisone/placebo) administered as described in this protocol | |||||||
| Follow-up | ||||||||
| Blood and urine sampling | X | X | X | X | ||||
| Daily collection of clinical data | X | X | X | X | X | X | X | X |
| Final visit | On the day of discharge from the hospital | |||||||
BP, blood pressure; PerLR, personal legal representative; ProLR, professional legal representative.