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

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 61

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
AND
b.PaO2/FiO2 = 300 mmHg (ARDS: PaO2/FiO2 = 200 mmHg)
AND
c.bilateral pulmonary infiltrates on a chest radiograph consistent with the presence of edema,
AND
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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of days alive and off ventilator until 28 days after randomisation (VFD)

Secondary Outcome Measures

Name	Time	Method
Renal function: (a) days alive and off renal replacement therapy until day 28, (b) chronic renal failure leading to renal replacement therapy in survivors at day 60 (c) mean daily fluid balance for day 0 to 5 (d) change of kidney function until day 28 based on serum creatinine \|\| Cardiovascular function: (a) days alive without vaso-active drugs until day 28 (VAS) (b) maximum and mean SOFA-subscore for the cardiovascular system for day 0 to day 28 (c) maximum vasopressor dose \|\| Survival at day 28 and day 60 (SV) \|\| Breathing without assistance at day 28 (%) \|\| Organ failure free days, except lung until 28 days after randomisation \|\| Highest Sequential Organ Failure Assessment score until 28 days after randomisation \|\| Days alive and outside ICU until 28 days after randomisation \|\| Change in PaO2/FiO2

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