A Phase 4 interventional study of cisatracurium and Placebo in ARDS, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 20 sites in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2008-10-10.
Sponsored by Assistance Publique Hopitaux De Marseille · Phase 4, Interventional, and Treatment
The use of neuromuscular blocking agents (NMBA) in ARDS patients has not been extensively investigated. The aim of the study is to show a reduction of the mortality rate of ARDS patients.
The use of neuromuscular blocking agents (NMBA) in ARDS patients has not been extensively investigated. It has been recently demonstrated that a systematic 48-h infusion of NMBA is associated with a significant improvement in oxygenation as compared with a control group (Gainnier et al., Crit Care Med 2004). Moreover, a trend towards a reduction in the mortality rate has been observed. The aim of the study is to show a reduction of the mortality rate of ARDS patients.
Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.
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Drug: Placebo
Drug: cisatracurium · Drug: Cisatracurium besilate
physiological serum infusion
Cisatracurium besilate infusion (900mg/day)
Reduction of the mortality rate of ARDS patients at d90
Time frame: 36 months
Mortality at day 28, day 60, day 180 and ICU mortality, Ventilator-free days and alive at day 28 and day 60, Exposure time to FIO2 > 80% or PEEP > 10 cmH2O during the first 7 days, Sedatives and analgesics requirements during the first 7 days
Time frame: march 2009
Organ failure-free days and alive at day 28, Incidence of barotrauma, Incidence of critical illness neuromyopathy, Incidence of ventilator-associated pneumonia, Quality of life at day 180
Time frame: march 2009
This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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Assistance Publique Hopitaux De Marseille