| Neuromuscular blockers in early acute respiratory distress syndrome. | |
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MedLine Citation:
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PMID: 20843245 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: In patients undergoing mechanical ventilation for the acute respiratory distress syndrome (ARDS), neuromuscular blocking agents may improve oxygenation and decrease ventilator-induced lung injury but may also cause muscle weakness. We evaluated clinical outcomes after 2 days of therapy with neuromuscular blocking agents in patients with early, severe ARDS. METHODS: In this multicenter, double-blind trial, 340 patients presenting to the intensive care unit (ICU) with an onset of severe ARDS within the previous 48 hours were randomly assigned to receive, for 48 hours, either cisatracurium besylate (178 patients) or placebo (162 patients). Severe ARDS was defined as a ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FIO2) of less than 150, with a positive end-expiratory pressure of 5 cm or more of water and a tidal volume of 6 to 8 ml per kilogram of predicted body weight. The primary outcome was the proportion of patients who died either before hospital discharge or within 90 days after study enrollment (i.e., the 90-day in-hospital mortality rate), adjusted for predefined covariates and baseline differences between groups with the use of a Cox model. RESULTS: The hazard ratio for death at 90 days in the cisatracurium group, as compared with the placebo group, was 0.68 (95% confidence interval [CI], 0.48 to 0.98; P=0.04), after adjustment for both the baseline PaO2:FIO2 and plateau pressure and the Simplified Acute Physiology II score. The crude 90-day mortality was 31.6% (95% CI, 25.2 to 38.8) in the cisatracurium group and 40.7% (95% CI, 33.5 to 48.4) in the placebo group (P=0.08). Mortality at 28 days was 23.7% (95% CI, 18.1 to 30.5) with cisatracurium and 33.3% (95% CI, 26.5 to 40.9) with placebo (P=0.05). The rate of ICU-acquired paresis did not differ significantly between the two groups. CONCLUSIONS: In patients with severe ARDS, early administration of a neuromuscular blocking agent improved the adjusted 90-day survival and increased the time off the ventilator without increasing muscle weakness. (Funded by Assistance Publique-Hôpitaux de Marseille and the Programme Hospitalier de Recherche Clinique Régional 2004-26 of the French Ministry of Health; ClinicalTrials.gov number, NCT00299650.) |
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Authors:
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Laurent Papazian; Jean-Marie Forel; Arnaud Gacouin; Christine Penot-Ragon; Gilles Perrin; Anderson Loundou; Samir Jaber; Jean-Michel Arnal; Didier Perez; Jean-Marie Seghboyan; Jean-Michel Constantin; Pierre Courant; Jean-Yves Lefrant; Claude Guérin; Gwenaël Prat; Sophie Morange; Antoine Roch; |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The New England journal of medicine Volume: 363 ISSN: 1533-4406 ISO Abbreviation: N. Engl. J. Med. Publication Date: 2010 Sep |
Date Detail:
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Created Date: 2010-09-16 Completed Date: 2010-09-23 Revised Date: 2012-05-02 |
Medline Journal Info:
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Nlm Unique ID: 0255562 Medline TA: N Engl J Med Country: United States |
Other Details:
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Languages: eng Pagination: 1107-16 Citation Subset: AIM; IM |
Affiliation:
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Assistance Publique-Hôpitaux de Marseille Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes, Centre National de la Recherche Scientifique-Unité Mixte de Recherche 6236, Université de la Méditerranée Aix-Marseille II, Marseille, France. laurent.papazian@ap-hm.fr |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00299650 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Atracurium
/
adverse effects,
analogs & derivatives*,
therapeutic use Combined Modality Therapy Double-Blind Method Humans Infusions, Intravenous Middle Aged Multiple Organ Failure Neuromuscular Blocking Agents / adverse effects, therapeutic use* Pneumothorax / epidemiology Proportional Hazards Models Respiration, Artificial* Respiratory Distress Syndrome, Adult / drug therapy*, mortality, therapy Survival Rate Treatment Outcome Ventilator Weaning / methods |
| Chemical | |
Reg. No./Substance:
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0/Neuromuscular Blocking Agents; 0/cisatracurium; 64228-79-1/Atracurium |
| Investigator | |
Investigator/Affiliation:
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J Albanese / ; V Blaso / ; M Leone / ; F Antonini / ; P Visintini / ; G Perrin / ; D Blayac / ; B Eon / ; P Michelet / ; P Saux / ; D Lambert / ; V Fulachier / ; J M Forel / ; A Roch / ; C Guervilly / ; J Allardet-Servent / ; D Demory / ; N Embriaco / ; M Gainnier / ; L Papazian / ; J M Seghboyan / ; N Beni Chougrane / ; R Soundaravelou / ; A Piera / ; M Bonnetty / ; E Azoulay / ; D Perez / ; G Capellier / ; P Midez / ; C Patry / ; E Laurent / ; E Belle / ; J C Navellou / ; J M Constantin / ; S Cayot-Constantin / ; R Guerin / ; P Courant / ; T Signouret / ; K Pavaday / ; P Garcia / ; L Delapierre / ; K Debbat / ; J M Arnal / ; J Durand-Gasselin / ; G Corno / ; A Orlando / ; I Granier / ; S Y Donati / ; A Gacouin / ; Y Le Tulzo / ; S Lavoue / ; C Camus / ; C Gervais / ; C Bengler / ; C Arich / ; J Y Lefrant / ; P Poupard / ; L Muller / ; P Joubert / ; R Cohendy / ; G Saissi / ; P Barbaste / ; C Guérin / ; F Bayle / ; J C Richard / ; J M Badet / ; G Hilbert / ; H Bruno / ; E Rosier / ; W Pujol / ; H N Bui / ; S Jaber / ; B Jung / ; M Sebbane / ; G Chanques / ; G Prat / ; E L'Her / ; J M Tonnelier / ; O Baldesi / ; C Leroy / ; L Rodriguez / ; J L Le Grand / ; B Garrigues / ; G Bernardin / ; J Dellamonica / ; C Schwebel / ; J F Timsit / ; R Hamidfar / ; L Hammer / ; G Dessertaine / ; C De Couchon / ; A Bonadona / ; F Zeni / ; D Thevenet / ; C Venet / ; S Guyomarc'h / |
| Comments/Corrections | |
Comment In:
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Crit Care. 2011;15(5):311
[PMID:
21970563
]
Can J Anaesth. 2012 Jan;59(1):105-8 [PMID: 22042702 ] N Engl J Med. 2010 Sep 16;363(12):1176-80 [PMID: 20843254 ] N Engl J Med. 2010 Dec 23;363(26):2563 [PMID: 21175320 ] N Engl J Med. 2010 Dec 23;363(26):2562; author reply 2563-4 [PMID: 21175322 ] N Engl J Med. 2010 Dec 23;363(26):2562-3; author reply 2563-4 [PMID: 21175321 ] Ann Intern Med. 2011 Jan 18;154(2):JC1-3 [PMID: 21242357 ] |
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