DRKS00000156CompletedPhase 2
ACE inhibitor for lung protection during mechanical Ventilation for acute lung injury - pilot trial - ACEmeVENT-Pilot
niversität Leipzig0 sites61 target enrollmentStarted: October 24, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 61
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (—)
- Sex
- All
Inclusion Criteria
- •1. intubated patients on mechanical ventilation and onset of ventilation not longer than 60h ago
- •2. Present (acute lung injury (ALI) / acute respiratory distress syndrome (ARDS)) defined by:
- •a. sudden onset
- •b.PaO2/FiO2 = 300 mmHg (ARDS: PaO2/FiO2 = 200 mmHg)
- •c.bilateral pulmonary infiltrates on a chest radiograph consistent with the presence of edema,
- •d. no clinical evidence of left atrial hypertension (e.g. as in heart failure); if measured, pulmonary-capillary wedge pressure of 18 mm Hg or less.
- •3.Age not less than18 years
- •4. Written informed consent of patient, person in charge or legal representative or acknowledgement of emergency situation by medical consultant
Exclusion Criteria
- •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/m2
- •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 during the last 12 months
- •b. after lung transplant
- •11. liver cirrhosis Child Pugh C
- •12. contraindications following the SmPC
- •13. Participation in another interventional clinical trials in the last 30 days
- •14. advanced relations to investigator
- •15. known nephrotic syndrome with proteinuira of >1g/day
- •16. clinical relevant electrolyte disorder in the assessment of the investigator
- •17. known immun disorder or collagen disease (i.e. lupus erythematodes, sklerodermia)
- •18. concomitant systemic therapy with immunsuppressives (i.e. corticosteroids, cytostatic agents, antimetabolite, allopurinol, procainamid or lithium) expect treatments of preexisting diseases or sepsis with glukokortikoids according to the respective guidelines.
Investigators
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