Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase: Completed; Phase 4

Conditions: ARDS

Treatments: Drug: Placebo; Drug: cisatracurium; Drug: Cisatracurium besilate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00299650

PHRC 2004

ACURASYS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 340 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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340 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Treatment:

Drug: Placebo

B

Active Comparator group

Treatment:

Drug: cisatracurium

Drug: Cisatracurium besilate