Table 1 SPIRIT schematic schedule of enrolment, interventions, and assessments

Inclusion and non-inclusion criteria

X

Informed consent

X

X⁽⁰⁾

X⁽⁰⁾

Randomization

X

Medical history/comorbidities

X

X

X*

Concomitant treatment

X

X

X*

Clinical examination

X⁽¹⁾

X⁽¹⁾

X* ⁽¹⁾

Blood sample for local biological assessment

X⁽²⁾

X⁽²⁾

Glasgow Coma Score

X

X

X*

Assessment of SOFA score

X

X

Molting score (picture of skin knees)

X

X**

Capillary refill time

X

X

biological collection

X, within the 12 first hours after randomization

Drug intake

X⁽³⁾

X⁽³⁾

Retrieval of adverse events

X

X

X

Assessment of morbidity and mortality

X

X

X