Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients - Full Text View

Purpose

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
ARDS	Drug: cisatracurium Drug: Placebo Drug: Cisatracurium besilate	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Cisatracurium besylate

U.S. FDA Resources

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:

Reduction of the mortality rate of ARDS patients at d90 [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

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
Placebo Comparator: A	Drug: Placebo physiological serum infusion
Active Comparator: B	Drug: cisatracurium Drug: Cisatracurium besilate Cisatracurium besilate infusion (900mg/day)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ARDS with a PaO2 / FiO2 < 150 with a PEEP > 5 since less than 48 hrs
informed consent

Exclusion Criteria:

NMBA allergy
Continuous administration of NMBA for ARDS prior inclusion
Age < 18 yrs
SAPS II > 70
Persistent air leak

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299650

Locations

France
Réanimation polyvalente
Aix en Provence, France
Réanimation Polyvalente
Avignon, France
Hôpital Jean Minjoz - Réanimation médicale
Besancon, France
Hôpital Pellegrin - Réanimation médicale
Bordeaux, France, France
Réanimation médicale
Brest, France
Réanimation chirurgicale
Clermont-Ferrand, France
Hôpital de la Tronche - Réanimation médicale
Grenoble, France
Hôpital de la croix rousse - Réanimation médicale
Lyon, France
Hôpital Ambroise Paré - Réanimation
Marseille, France, 13000
Réanimation Polyvalente - Hôpital Sainte-Marguerite
Marseille, France, 13009
Hôpital Nord - Réanimation
Marseille, France, 13015
Hôpital Sainte-Marguerite - Réanimation médicale
Marseille, France, 13009
Réanimation chirurgicale
Montpellier, France
Réanimation médicale
Nice, France
Réanimation Médicale
Nimes, France
Réanimation chirurgicale
Nimes, France
Hôpital Saint-Louis - Réanimation médicale
Paris, France
Hôpital Pontchaillou - Réanimation médicale
Rennes, France
Hôpital Bellevue - Réanimation Médicale
Saint-Etienne, France
Réanimation polyvalente
Toulon, France

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

GlaxoSmithKline

Investigators

Principal Investigator:

Laurent Papazian, MD

Assistance Publique Hôpitaux de Marseille

More Information

No publications provided by Assistance Publique Hopitaux De Marseille

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guérin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16.

Responsible Party:	Pr PAPAZIAN Laurent, ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
ClinicalTrials.gov Identifier:	NCT00299650 History of Changes
Other Study ID Numbers:	ACURASYS, PHRC 2004
Study First Received:	March 6, 2006
Last Updated:	October 9, 2008
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique Hopitaux De Marseille:

ARDS
mortality
mechanical ventilation
pneumonia
muscle relaxants

Additional relevant MeSH terms:

Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Neuromuscular Blocking Agents
Cisatracurium
Atracurium
Neuromuscular Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neuromuscular Nondepolarizing Agents

ClinicalTrials.gov processed this record on May 16, 2013