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. - Balcapulco

Conditions: adult patients affected by pulmonary contusion from chest trauma at risk of ALI/ARDS
MedDRA version: 9.1Level: LLTClassification code 10061230Term: Lung injury

Registration Number: EUCTR2006-002550-30-IT

Lead Sponsor: CHIESI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

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 8804; 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. -Informed Consent
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 at PEEP 12 mbar - 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 at time of 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 23 . - 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and safety of Curosurf Poractant Alfa, porcine surfactant administered by bronchoalveolar lavage BAL in terms of reduction of duration of intubation days , in adult patients with pulmonary contusion.;Secondary Objective: Response rates under standard conditions PaO2/FiO2 ratio and Ventilation Index VI RRx PIP-PEEP xPaCO2/1000. Occurrence of complications as;Primary end point(s): Reduction of duration of intubation days by 30 for the treated group compared to the control group. Successful extubation is defined as no need for re-intubation within 48 hours. Non-invasive ventilation support can be accepted and must be documented.

Secondary Outcome Measures