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Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00299650
First Posted: March 7, 2006
Last Update Posted: October 10, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by:
Assistance Publique Hopitaux De Marseille
March 6, 2006
March 7, 2006
October 10, 2008
March 2006
October 2008   (Final data collection date for primary outcome measure)
Reduction of the mortality rate of ARDS patients at d90 [ Time Frame: 36 months ]
Reduction of the mortality rate of ARDS patients at d90
Complete list of historical versions of study NCT00299650 on ClinicalTrials.gov Archive Site
  • 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 ]
  • - Mortality at day 28, day 60, day 180 and ICU mortalit
  • - 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
  • - 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
Not Provided
Not Provided
 
Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients
Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
ARDS
  • Drug: cisatracurium
  • Drug: Placebo
    physiological serum infusion
  • Drug: Cisatracurium besilate
    Cisatracurium besilate infusion (900mg/day)
  • Placebo Comparator: A
    Intervention: Drug: Placebo
  • Active Comparator: B
    Interventions:
    • Drug: cisatracurium
    • Drug: Cisatracurium besilate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
340
October 2008
October 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00299650
ACURASYS
PHRC 2004
Yes
Not Provided
Not Provided
Pr PAPAZIAN Laurent, ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
Assistance Publique Hopitaux De Marseille
GlaxoSmithKline
Principal Investigator: Laurent Papazian, MD Assistance Publique Hôpitaux de Marseille
Assistance Publique Hopitaux De Marseille
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP