A clinical study on the application of physostigminsalicylate (Anticholium®) as auxiliary measure in perioperative blood poisoning/its life-threatening form

Phase 1

• Conditions: MedDRA version: 19.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-001650-26-DE
• Lead Sponsor: Ruprecht-Karls-University Heidelberg, Med Faculty represented by Universitätsklinikum Heidelberg and its Commercial D

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-14
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Up for inclusion are all patients who fulfil all of the following criteria
1. Age at least 18 and not more than 85 years
2. APACHE II-Score < 34
3. intraabdominal infection (less than 24 hours existing)
finding of a diffuse peritonitis or
of a localised abscess

4. perioperative sepsis and
verified evidence of an infection
clinically verified or
microbiologically verified
and at least two of the following four criteria
- fever = 38,0 °C or
hypothermia = 36,0 °C verified through rectal or intravesical or intravasal measurement
- tachycardia = 90/min
- tachypnoea = 20/min or
hyperventilation verified through taking of an arterial blood gas analysis with PaCO2 = 4,3 kPa or 33 mmHg or
mechanical/artificial ventilation
- leukocytosis = 12.000/mm3 or
leukopenia = 4.000/mm3 or
= 10 % immature neutrophils in the differential blood count
5. shock (less than 24 hours existing)
necessary use of vasopressors* despite sufficient fluid administration** to keep (the systolic arterial pressure = 90 mmHg or) the mean arterial pressure = 70 mmHg
6. no more than one scheduled and/or one emergency procedure since admission (no repeated revisions)
7. no infaust prognosis of a underlying or concomitant disease that gives reason to expect the death within the follow-up period
8. no do-not-resuscitate order
9. written consent of the full aged patient/her/his legal representative to participation (written consent (according to AMG [German drug law] §40 (1) 3B))

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Up for exclusion are all patients who fulfil at least one of the following criteria:
1. known oversensitivity towards physostigminsalicylate, sodiummetabisulphite, sodiumethylenediaminetetraacetic acid or one of the remaining ingridients of Anticholium®
2. known contraindications* against Anticholium®
- gangrene
- coronary heart disease
3. known absolute contraindications* against Anticholium®
- myotonic dytrophy
- depolarization block after depolarising muscle relaxants
- intoxications through irreversible acting” cholinesterase inhibitors
- closed traumatic brain injuries
- obstructions in the gastrointestinal tract (mechanic constipation)
- obstructions in the urinary tract (mechanic urinary retention)
4. known relative contraindications* against Anticholium®
- bronchial asthma
- bradycardia
- AV-conduction disorders
5. status post splenectomy
6.status post organ transplantation
7. positive pregnancy test, pregnancy and breastfeeding
8. participation in another clinical trial according to AMG or the follow-up period of another trial according to the AMG

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified