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Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

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.
 
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

Tracking Information
First Submitted Date  ICMJE March 6, 2006
First Posted Date  ICMJE March 7, 2006
Last Update Posted Date October 10, 2008
Study Start Date  ICMJE March 2006
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
Reduction of the mortality rate of ARDS patients at d90 [ Time Frame: 36 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2006)
Reduction of the mortality rate of ARDS patients at d90
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2006)
  • - 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients
Official Title  ICMJE Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE ARDS
Intervention  ICMJE
  • Drug: cisatracurium
  • Drug: Placebo
    physiological serum infusion
  • Drug: Cisatracurium besilate
    Cisatracurium besilate infusion (900mg/day)
Study Arms  ICMJE
  • Placebo Comparator: A
    Intervention: Drug: Placebo
  • Active Comparator: B
    Interventions:
    • Drug: cisatracurium
    • Drug: Cisatracurium besilate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 6, 2006)
340
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00299650
Other Study ID Numbers  ICMJE ACURASYS
PHRC 2004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pr PAPAZIAN Laurent, ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Laurent Papazian, MD Assistance Publique Hôpitaux de Marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date October 2008

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