EUCTR2006-002550-30-AT进行中（未招募）不适用
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
Chiesi Farmaceutici S. p. A.0 个研究点目标入组 120 人开始时间: 2006年10月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-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
排除标准
- •-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.)
研究者
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