A comparative, randomised controlled trial for evaluating the efficacy of dexamethasone administration in the treatment of patients with the Acute Respiratory Distress Syndrome

Jesús Villar Hernández0 个研究点开始时间: 2012年7月19日最近更新: 2012年12月17日

研究概览

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•To be eligible for inclusion into this study (Day 0), each patient must fulfil the following inclusion criteria during screening and prior to the enrolment into the study:
•a.Age >=18 years old
•b.Patients must have acute onset of ARDS, as defined by the American-European Consensus Conference (AECC) criteria for ARDS:
•i.Having an initiating clinical condition (pneumonia, aspiration, inhalation injury, sepsis, trauma, acute pancreatitis, etc.).
•ii.bilateral infiltrates on frontal chest radiograph
•iii.absence of left atrial hypertension, a pulmonary capillary wedge pressure (PCWP) less than 18 mm Hg, or no clinical signs of left heart failure
•iv.severe hypoxemia (a PaO2/FIO2 <=200 mm Hg, regardless of FIO2 or positive end-expiratory pressure (PEEP)
•c.Be intubated and mechanically ventilated
•d.Have provided signed written informed consent from the patient or the patient's personal legal representative.
•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 264
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•To be eligible for inclusion into this study (Day 0), each patient must not have any of the following exclusion criteria during screening and prior to the enrolment into the study:
•e.Be a woman known to be pregnant or lactating
•f.Take part in another experimental treatment protocol (simultaneously)
•g.Brain death
•h.Terminal-stage cancer or other terminal disease
•i.Having do-not-resuscitate orders
•j.Being immune-compromised
•k.Receiving corticosteroids or immunosuppressive drugs
•l.Patients in whom more than 24 hours had elapsed after initially meeting the AECC ARDS criteria before consent and results of initial standard ventilator settings could be obtained.
•m.Have severe chronic obstructive pulmonary disease (COPD)
•n.Have congestive heart failure

发起方

Jesús Villar Hernández