A randomized controlled pilot study for the comparison of efficacy of bronchoalveolar lavage (BAL) with Curosurf® in a dosage 50 mg/kg vs not treated control in adult patients affected by pulmonary contusion from chest trauma at risk of ALI/ARDS using low tidal volume ventilation treatment. Suggested Acronym:BALCAPULCO (BAL with Curosurf® in Adults with PULmonary COntusion) - BALCAPULCO

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

-The subject must be between 18 - 70 years of age
-The subjects must have a diagnosis based on clinical signs and /or radiographic and CT scan evidence of uni- or bilateral lung contusion involving one or more lobes
-Subject must be intubated and artificially ventilated
-Subject must be at ICU and randomised to one of the study arms within = 6 hours of trauma
-Subject must be in a clinically stable condition with efficacious, stable ventilation support for one hour before BAL, which therefore must be performed after a maximum of 7 hours from trauma.

-Evidence for date and time of the trauma must be available; the maximum admissible time uncertainty must not exceed 30 minutes.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Subjects with an anamnestically known hypersensitivity against surfactants
-Subject is female with childbearing potential and a (in such cases mandatory) pregnancy test is positive
-Subjects who have at least one other source of severe lung injury due to inhalation of toxic gases, burnings, acids or similar substances in addition to the lung contusion
-Subjects who suffer from anamnestically known chronic lung disease (COPD) Stage III
-Subjects who suffer from anamnestically known status asthmaticus
-Subject with severe ventilation refractory hypoxemia: paO2/FiO2 < 50 with PEEP > 12 mbar during stabilisation on ICU
-Subjects with congestive heart failure and/or uncorrected congenital heart disease
-Subjects with cardiogenic pulmonary edema
-Subjects who have their hemo- and/or pneumothorax not adequately resolved several minutes prior randomisation.
-Subjects who need abdominal and/or lung surgery
-Subjects with severe brain injury (Glasgow Coma Scale < 10), need for neurosurgery, brain death
-Terminal patients with an estimated life expectancy of less than 4 weeks
-Subjects who are treated with another surfactant during the whole study period
-Subject´s demand for another experimental drug
-Subject´s demand for medications which could be dangerous for the patient according to their SPC
-Subject´s demand for non depolarizing muscle relaxants (except during bronchoscopy)
-Subjects with presence of abdominal lesions which are known to create severe post-operative complications (e.g. sepsis, delay in intestinal canalization, etc.)
-Subjects with a Body Mass Index BMI > 30.
-Subject is anamnestically known for participation in other clinical studies or termination of other clinical trials within two months prior trauma.
-Subjects with available evidence of legal restrictions for their ability to provide informed consent (e.g., soldiers, prisoners, severe mental diseases, severe drug addiction etc.)