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

Phase 1

• Conditions: acute lung injury, ALI/ARDS; MedDRA version: 17.1Level: PTClassification code 10001052Term: Acute respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 17.1Level: PTClassification code 10069351Term: Acute lung injurySystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2010-020403-75-DE
• Lead Sponsor: niversität Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-16
• Study Completion: 2016-01-17
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

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
and
b. PaO2/FiO2 = 300 mmHg (ARDS: PaO2/FiO2 = 200 mmHg)
and
c. bilateral pulmonary shadows apparent on chest x-ray which are conformable with a edema
and
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

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/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

Study & Design

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