Clinical trial NCT00299650: Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients
Official title: Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ARDS
Keywords: ARDS
mortality
mechanical ventilation
pneumonia
muscle relaxants
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2006-03-07
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Reduction of the mortality rate of ARDS patients at d90
timeFrame: 36 months
Secondary outcomes:
measure: 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
timeFrame: march 2009
measure: 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
timeFrame: march 2009
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Réanimation polyvalente
city: Avignon
country: France
facility: Réanimation Polyvalente
city: Besancon
country: France
facility: Hôpital Jean Minjoz - Réanimation médicale
city: Bordeaux
country: France
facility: Hôpital Pellegrin - Réanimation médicale
city: Brest
country: France
facility: Réanimation médicale
city: Clermont-Ferrand
country: France
facility: Réanimation chirurgicale
city: Grenoble
country: France
facility: Hôpital de la Tronche - Réanimation médicale
city: Lyon
country: France
facility: Hôpital de la croix rousse - Réanimation médicale
city: Marseille
country: France
facility: Hôpital Ambroise Paré - Réanimation
city: Marseille
country: France
facility: Hôpital Sainte-Marguerite - Réanimation médicale
city: Marseille
country: France
facility: Réanimation Polyvalente - Hôpital Sainte-Marguerite
city: Marseille
country: France
facility: Hôpital Nord - Réanimation
city: Montpellier
country: France
facility: Réanimation chirurgicale
city: Nice
country: France
facility: Réanimation médicale
city: Nimes
country: France
facility: Réanimation chirurgicale
city: Nimes
country: France
facility: Réanimation Médicale
city: Paris
country: France
facility: Hôpital Saint-Louis - Réanimation médicale
city: Rennes
country: France
facility: Hôpital Pontchaillou - Réanimation médicale
city: Saint-Etienne
country: France
facility: Hôpital Bellevue - Réanimation Médicale
city: Toulon
country: France
facility: Réanimation polyvalente
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Laurent Papazian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guerin C, Papazian L, Reignier J, Ayzac L, Loundou A, Forel JM; investigators of the Acurasys and Proseva trials. Effect of driving pressure on mortality in ARDS patients during lung protective mechanical ventilation in two randomized controlled trials. Crit Care. 2016 Nov 29;20(1):384. doi: 10.1186/s13054-016-1556-2.
citation: 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, Guerin 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. doi: 10.1056/NEJMoa1005372.