Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00299650
First received: March 6, 2006
Last updated: October 9, 2008
Last verified: October 2008

March 6, 2006
October 9, 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 ] [ Designated as safety issue: Yes ]
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 ] [ 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 ]
  • - 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
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.

*   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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00299650
ACURASYS, PHRC 2004
Yes
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