ACE inhibitor for lung protection during mechanical Ventilation for acute lung injury - pilot trial - ACEmeVent-Pilot

niversität Leipzig0 个研究点目标入组 58 人开始时间: 2011年6月16日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•1. invasive mechanical ventilation and begin of ventilation dates back a maximum of 60 hours
•2. acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) defined by
•a. sudden beginn of pulmonary failure
•b. PaO2/FiO2 = 300 mmHg (ARDS: PaO2/FiO2 = 200 mmHg)
•c. bilateral pulmonary shadows apparent on chest x-ray which are conformable with a edema
•d. exclusion of a left cardiac insufficiency as source of the edema, i.e. pumonary closing pressure =18mmHg, if measured or absent signs of a clinically manifest left cardiac insufficiency.
•3. Age at least 18 years
•4. written informed consent by patient or legal or authorized representative
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•1. positive pregnancy test in women with childbearing potential
•2. nursing women
•3. unsuggestive of elevatetd intracraniell pressure
•4. unsuggestive of neuromuscular diseases, if they are likely to affect spontaneous breathing
•5. known sickle cell anaemia
•6. severe chronic respiratory insufficiency in pre-existing pulmonary disease
•7. severe adiposity > 45 kg/qm
•8. burns of more than 30% of the body surface area
•9. other medical conditions with an expected 6-months mortality >50%
•10. Patients
•a. after bone marrow- or stem cell transplant in the past 12 months
•b. lung transplant
•11. liver cirrhosis Child Pugh C
•12. contraindications following the SmPC except for renal function disorders and renal replacement therapy
•13. Participation in another interventional clinical trials
•14. advanced relations to investigator

发起方

niversität Leipzig