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Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

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ClinicalTrials.gov Identifier: NCT00299650
Recruitment Status : Completed
First Posted : March 7, 2006
Last Update Posted : October 10, 2008
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Assistance Publique Hopitaux De Marseille

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
ARDS Drug: cisatracurium Drug: Placebo Drug: Cisatracurium besilate Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients
Study Start Date : March 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: A Drug: Placebo
physiological serum infusion
Active Comparator: B Drug: cisatracurium
Drug: Cisatracurium besilate
Cisatracurium besilate infusion (900mg/day)


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of the mortality rate of ARDS patients at d90 [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299650


Locations
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Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
GlaxoSmithKline
Investigators
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Principal Investigator: Laurent Papazian, MD Assistance Publique Hôpitaux de Marseille
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pr PAPAZIAN Laurent, ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
ClinicalTrials.gov Identifier: NCT00299650    
Other Study ID Numbers: ACURASYS
PHRC 2004
First Posted: March 7, 2006    Key Record Dates
Last Update Posted: October 10, 2008
Last Verified: October 2008
Keywords provided by Assistance Publique Hopitaux De Marseille:
ARDS
mortality
mechanical ventilation
pneumonia
muscle relaxants
Additional relevant MeSH terms:
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Cisatracurium
Atracurium
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Neuromuscular Nondepolarizing Agents
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action