Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

ARDS Clinical Trial

Official title:

Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00299650
• Other study ID #: ACURASYS
• Secondary ID: PHRC 2004
• Status: Completed
• Phase: Phase 4
• First received: March 6, 2006
• Last updated: October 9, 2008
• Start date: March 2006
• Est. completion date: October 2008

Study information

• Verified date: October 2008
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ARDS

Intervention

Drug:
• cisatracurium

• Placebo
physiological serum infusion
• Cisatracurium besilate
Cisatracurium besilate infusion (900mg/day)

Locations

Country	Name	City	State
France	Réanimation polyvalente	Aix en Provence
France	Réanimation Polyvalente	Avignon
France	Hôpital Jean Minjoz - Réanimation médicale	Besancon
France	Hôpital Pellegrin - Réanimation médicale	Bordeaux
France	Réanimation médicale	Brest
France	Réanimation chirurgicale	Clermont-Ferrand
France	Hôpital de la Tronche - Réanimation médicale	Grenoble
France	Hôpital de la croix rousse - Réanimation médicale	Lyon
France	Hôpital Ambroise Paré - Réanimation	Marseille
France	Hôpital Nord - Réanimation	Marseille
France	Hôpital Sainte-Marguerite - Réanimation médicale	Marseille
France	Réanimation Polyvalente - Hôpital Sainte-Marguerite	Marseille
France	Réanimation chirurgicale	Montpellier
France	Réanimation médicale	Nice
France	Réanimation chirurgicale	Nimes
France	Réanimation Médicale	Nimes
France	Hôpital Saint-Louis - Réanimation médicale	Paris
France	Hôpital Pontchaillou - Réanimation médicale	Rennes
France	Hôpital Bellevue - Réanimation Médicale	Saint-Etienne
France	Réanimation polyvalente	Toulon

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille	GlaxoSmithKline

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of the mortality rate of ARDS patients at d90		36 months	Yes
Secondary	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		march 2009	Yes
Secondary	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		march 2009	Yes