Last updated on February 2018

Anticholium Per Se

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Perioperative Period | Toxic Shock Syndrome | Septicemia
  • Age: Between 18 - 85 Years
  • Gender: Male or Female

Inclusion 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/mm or leukopenia 4000/mm 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 basis/as an 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 40 (1) 3b)] and unable to consent adults [ 41 (1) 2 AMG)]

Exclusion criteria

  • Known hypersensitivity to physostigmine salicylate, sodium metabisulfite, sodium EDTA, or any of the other ingredients of Anticholium
  • Known contraindications against Anticholium: gangrene, coronary artery disease
  • Known absolute contraindications 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 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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