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. 2021 Feb 16;11(2):e043194. doi: 10.1136/bmjopen-2020-043194

Table 1.

STRESS-L schedule of interventions

Procedure (time (T) in days/hours) Screening (T0–12) Baseline (day 0–24 hours—T0) Day 1 (T0+24) Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12 Day 13 Day 14 EONT visit FU visit day 28 Final visit day 90
Eligibility assessment
Informed consent
Randomisation
Demographics
Medical history
ECG According to clinical need or if adverse event (AE)/serious AE (SAE)
Pregnancy test
IMP Dispense End
Blood sample
Biobank blood sample (optional)
Transport of stored serum Batch
Local laboratory tests (normal clinical care):
 C reactive protein
 Glucose
 Lactate
 Worst PaO2/FiO2
 Platelets
 Creatinine
 Bilirubin
 White cell count
 Liver function tests (ALT or AST)
Central venous blood gas (BG)/ arterial BG
Microbiology results from local lab
Heart rate (hourly: T0+7 days)
Atrial fibrillation (hourly: T0+7 days)
Blood pressure (hourly: T0+7 days)
Rate of vasopressor/inotropes
In/out fluids
SOFA score
AEs (SAEs up to day 90)
Steroid use
Compliance
Mortality status
End of trial

ALT, alanine aminotransferase; AST, aspartate aminotransferase; EONT, end of norepinephrine treatment; FiO2, fractional inspired oxygen; FU, follow-up; IMP, investigational medicinal product; PAO2, arterial oxygen tension; SOFA, Sequential Organ Failure Assessment.