EUCTR2012-001650-26-DE进行中（未招募）1 期
A randomised, placebo-controlled, double-blind, monocentre study on the application of physostigminsalicylate (Anticholium®) as adjunctive measure in perioperative sepsis/septic shock - Anticholium per Se
Ruprecht-Karls-University Heidelberg, Med Faculty represented by Universitätsklinikum Heidelberg and its Commercial D0 个研究点目标入组 20 人开始时间: 2012年8月14日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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