Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

Phase 4

Completed

• Conditions: ARDS
• Interventions: Drug: Placebo; Drug: cisatracurium; Drug: Cisatracurium besilate

• Registration Number: NCT00299650
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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 Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-06
• Study First Submitted QC: 2006-03-06
• Study First Posted: 2006-03-07
• Status Verified: 2008-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Last Update Submitted: 2008-10-09
• Last Update Posted: 2008-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Placebo	-
B	Cisatracurium besilate	-
B	cisatracurium	-

Primary Outcome Measures

Name	Time	Method
Reduction of the mortality rate of ARDS patients at d90	36 months

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (16)

Réanimation chirurgicale; 🇫🇷 Nimes, France

Réanimation Polyvalente; 🇫🇷 Avignon, France

Hôpital de la Tronche - Réanimation médicale; 🇫🇷 Grenoble, France

Réanimation médicale; 🇫🇷 Nice, France

Réanimation Médicale; 🇫🇷 Nimes, France

Hôpital Jean Minjoz - Réanimation médicale; 🇫🇷 Besancon, France

Hôpital Pontchaillou - Réanimation médicale; 🇫🇷 Rennes, France

Hôpital de la croix rousse - Réanimation médicale; 🇫🇷 Lyon, France

Hôpital Sainte-Marguerite - Réanimation médicale; 🇫🇷 Marseille, France

Hôpital Saint-Louis - Réanimation médicale; 🇫🇷 Paris, France

Hôpital Bellevue - Réanimation Médicale; 🇫🇷 Saint-Etienne, France

Hôpital Pellegrin - Réanimation médicale; 🇫🇷 Bordeaux, France

Hôpital Ambroise Paré - Réanimation; 🇫🇷 Marseille, France

Hôpital Nord - Réanimation; 🇫🇷 Marseille, France

Réanimation Polyvalente - Hôpital Sainte-Marguerite; 🇫🇷 Marseille, France

Réanimation polyvalente; 🇫🇷 Toulon, France