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Sponsors and Collaborators: |
Assistance Publique Hopitaux De Marseille GlaxoSmithKline |
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Information provided by: | Assistance Publique Hopitaux De Marseille |
ClinicalTrials.gov Identifier: | NCT00299650 |
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.
Condition | Intervention | Phase |
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ARDS |
Drug: cisatracurium Drug: Placebo Drug: Cisatracurium besilate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients |
Estimated Enrollment: | 340 |
Study Start Date: | March 2006 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Placebo Comparator |
Drug: Placebo
physiological serum infusion
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B: Active Comparator |
Drug: cisatracurium
Drug: Cisatracurium besilate
Cisatracurium besilate infusion (900mg/day)
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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.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Hôpital Sainte-Marguerite - Réanimation médicale | |
Marseille, France, 13009 | |
Réanimation Polyvalente - Hôpital Sainte-Marguerite | |
Marseille, France, 13009 | |
Hôpital Nord - Réanimation | |
Marseille, France, 13015 | |
Hôpital Ambroise Paré - Réanimation | |
Marseille, France, 13000 | |
Hôpital Saint-Louis - Réanimation médicale | |
Paris, France | |
Hôpital Jean Minjoz - Réanimation médicale | |
Besancon, France | |
Hôpital Pontchaillou - Réanimation médicale | |
Rennes, France | |
Réanimation médicale | |
Brest, France | |
Hôpital Pellegrin - Réanimation médicale | |
Bordeaux, France, France | |
Hôpital de la croix rousse - Réanimation médicale | |
Lyon, France | |
Réanimation chirurgicale | |
Montpellier, France | |
Hôpital Bellevue - Réanimation Médicale | |
Saint-Etienne, France | |
Réanimation chirurgicale | |
Clermont-Ferrand, France | |
Réanimation Polyvalente | |
Avignon, France | |
Réanimation polyvalente | |
Aix en Provence, France | |
Réanimation polyvalente | |
Toulon, France | |
Réanimation médicale | |
Nice, France | |
Réanimation Médicale | |
Nimes, France | |
Réanimation chirurgicale | |
Nimes, France | |
Hôpital de la Tronche - Réanimation médicale | |
Grenoble, France |
Principal Investigator: | Laurent Papazian, MD | Assistance Publique Hôpitaux de Marseille |
Responsible Party: | ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE ( Pr PAPAZIAN Laurent ) |
Study ID Numbers: | ACURASYS, PHRC 2004 |
Study First Received: | March 6, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00299650 |
Health Authority: | France: Ministry of Health |
ARDS mortality mechanical ventilation pneumonia muscle relaxants |
Cisatracurium Muscle Hypotonia Atracurium Pneumonia |
Neuromuscular Nondepolarizing Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Nicotinic Antagonists Physiological Effects of Drugs |
Neuromuscular Agents Neuromuscular Blocking Agents Peripheral Nervous System Agents Cholinergic Agents Pharmacologic Actions |