The H1N1 flu pandemic is one of the major infectious threat of the past half century. it is rapidly progressing worldwide and a substantial number of patients get severe H1N1 related pneumonia that requires mechanical ventilation and admission to the intensive care unit. The acute respiratory distress syndrome is associated with a substantial mortality and morbidity partly as a consequence of uncontrolled lung and systemic inflammation. many physicians are trying to counteract this pro-inflammatory storm by the use of corticosteroids albeit these drugs may cause super infection or metabolic disorders. Thus, there is a need for a randomized double blind, placebo controlled trial to define the benefit to risk ratio of corticosteroids in this patient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
50mg intravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week
intravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week
Raymond Poincaré hospital
Garches, France
in hospital all cause morality
Time frame: hospital discharge up to 90 days
28 day mortality
Time frame: 28 day
90 day all cause mortality
Time frame: 90 day
6 month all cause mortality
Time frame: 180 days
mechanical ventilation free days
Time frame: hospital discharge up to 90 days
intensive care unit free days
Time frame: hospital discharge up to 90 days
proportion of patients with secondary infections
Time frame: hospital discharge up to 90 days
proportion of patients who require ECMO
Time frame: hospital discharge up to 90 days
respiratory function and health status
Time frame: 180 days
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