Adjunctive use of physostigmine salicylate (Anticholium®) in perioperative sepsis and septic shock: study protocol for a randomized, double-blind, placebo-controlled, monocentric trial (Anticholium® per Se)

Table 2 Flow chart of visits, interventions, and data collected for the outcomes

AE adverse events, PD pharmacodynamics, PK pharmacokinetics, SAE serious adverse events
^aDuring administration of trial medication (initial dose), patients are continuously monitored by a physician attentive to the occurrence of side effects, AEs, and SAEs
^bMarked visits do not include any additional collection of blood (no second tube for IL-6 and thrombin-antithrombin complex)
^cVisit 1 including visit 1.1 with two blood samples [3 min after the start of the initial dose and at the end of the initial dose (±2 min)], visit 1.2 with three blood samples [10, 20, and 30 min after the start of continuous infusion (±2 min)], visit 1.3 with one blood sample [after 1 h (±10 min)]
^dVisit 7 including visit 7.1 with one blood sample [at the end of the infusion period (±2 min)], visit 7.2 with three blood samples [10, 20, and 30 min after the end of the infusion period (±2 min)], visit 7.3 with two blood samples [after 1 and 2 h (±10 min)]

ISSN: 1745-6215