lung contusion
Conditions
Interventions
Product Name: Curosurf
Product Code: surfactant
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: surfactant
Sponsors
Chiesi Farmaceutici S. p. A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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 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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Primary end point(s): Reduction of duration of intubation (days) in the treated group compared to the control group . The achieved extubation must be maintained for at least 48 hours (succesful extubation). Non-invasive ventilation support can be accepted and must be documented. ;Secondary Objective: Response rates under standard conditions: PaO2/FiO2 ratio and Ventilation Index (VI)= RRx(PIP-PEEP)xPaCO2/1000. Occurrence of complications as pulmonary emphysema and pneumothorax (barotrauma), pulmonary haemorrhage, radiographic and/or bacteriological verified nosocomial infections of the lung and ARDS according to AECC. LIS (lung injury score) Re-intubation due to other reasons (e. g. organic psycho syndrome (OPS), new aspiration, etc.) which are not related to the original lung contusion. Change in chest X-ray at baseline, 24 hours after treatment and discharge from ICU Mortality rate Total time and percentage of concentration of O2 after extubation Spirometry at discharge from ICU and/or from hospital (optional) | — |
Countries
Austria, Italy
Outcome results
None listed