Table 1.

Schedule of enrolment, interventions, assessments and data collection

	Study Period
	Enrollment / Baseline	Intervention (5 days)					Follow-up
Time point	D0	D1	D2	D3	D4	D5	D6	D28
Enrollment:
Eligibility screen	Χ
Informed consent	Χ
Randomization	Χ
Interventions:
Xuebijing injection		Χ	Χ	Χ	Χ	Χ
Normal saline		Χ	Χ	Χ	Χ	Χ
Assessments:
Demographic data	Χ
Etiological examination	Χ
Primary disease condition	Χ
General condition	Χ			Χ			Χ
SOFA score	Χ			Χ			Χ
APACHE Ⅱ score	Χ			Χ			Χ
Drugs	Χ	Χ	Χ	Χ	Χ	Χ	Χ	X
Safety	X						Χ
AEs		Χ	Χ	Χ	Χ	Χ
Mechanical ventilation/CRRT								Χ
Duration of stay in the ICU								Χ
Time and cost of hospitalisation								Χ
Survival condition								Χ

AEs, adverse events; APACHE II, Acute Physiology and Chronic Health Evaluation II; CRRT, continuous renal replacement therapy; ICU, intensive care unit; SOFA, Sequential Organ Failure Assessment.