The scientific rationale and study protocol for the DPP3, Angiotensin II, and Renin Kinetics in Sepsis (DARK-Sepsis) randomized controlled trial: serum biomarkers to predict response to angiotensin II versus standard-of-care vasopressor therapy in the treatment of septic shock

Table 3 Biomarker assay schedule

Time point	Angiotensin II arm	Control (SOC) arm
Pre-baseline	Randomization	Randomization
Baseline (T0)	Drug initiation	2 h post-randomization
1 h	1 h post-drug initiation^a	3 h post-randomization^a
3 h	3 h post-drug initiation^a	5 h post-randomization^a
24 h	24 h post-initiation^b	26 h post-randomization^b
Post-discontinuation	24 h post-drug discontinuation^c	N/A

SOC schedule built on estimation that time from randomization to study drug initiation will be approximately 2 h. ^a ± 15 min. ^b ± 30 min. ^c ± 8 h. Abbreviations: SOC standard of care

ISSN: 1745-6215