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Table 1 Eligibility criteria for participants

From: 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)

Inclusion criteria Exclusion criteria
• Age 18–85 years
• APACHE II score < 34
• Intra-abdominal infection
 ◦ findings of diffuse peritonitis or
 ◦ a circumscribed abscess
• Perioperative sepsis and
 ◦ secure evidence of infection,
 ◦ clinically backed up or
 ◦ secured microbiologically
 ◦ ≥ 2 of the following four criteria:
  ▪ fever ≥ 38.0 °C or
  ▪ hypothermia ≤ 36.0 °C secured by rectal intravesical or intravascular measurement
  ▪ tachycardia ≥ 90/min
  ▪ tachypnea ≥ 20/min or
  ▪ hyperventilation secured by arterial blood gas analysis with PaCO2 ≤ 4.3 kPa or 33 mmHg or
  ▪ mechanical artificial respiration
  ▪ leukocytosis ≥ 12,000/mm3 or
  ▪ leukopenia ≤ 4000/mm3 or
  ▪ ≥ 10% immature neutrophils in the differential count
• Shock (<24 h duration): necessary use of vasopressors despite adequate fluid resuscitation to keep systolic blood pressure ≥ 90 mmHg or mean blood pressure ≥ 70 mmHg
• No more than one planned and/or one emergency procedure performed since admission (no repeated revisions)
• No infaust prognosis of a primary or concomitant illness, expecting the death within the follow-up phase
• No do-not-resuscitate order
• Written informed consent of full-age patients/their legal guardian to participate (written consent, according to AMG)
• Known hypersensitivity to physostigmine salicylate, sodium metabisulfite, sodium EDTA, or any of the other ingredients of Anticholium®
• Known contraindications [7] against Anticholium®: gangrene, coronary artery disease
• Known absolute contraindications [7] against Anticholium®: myotonic dystrophy; depolarization block by depolarizing muscle relaxants; intoxication by “irreversibly acting” cholinesterase inhibitors; closed craniocerebral trauma; obstruction in the gastrointestinal tract (mechanical constipation); obstruction in the urinary tract (mechanical urinary retention)
• Known relative contraindications [7] against Anticholium®: bronchial asthma; bradycardia; AV-conduction disturbances
• Having undergone splenectomy
• Having undergone solid organ transplantation
• Positive pregnancy test, pregnancy, and lactation
• Participation in another clinical trial, according to AMG or the follow-up phase of another study, according to AMG
  1. AMG Medicinal Products Act, APACHE Acute Physiology And Chronic Health Evaluation, AV atrioventricular, PaCO 2 partial pressure of carbon dioxide