Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

Assistance Publique Hopitaux De Marseille340 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

340

Conditions

ARDS

Interventions

cisatracuriumDRUG

PlaceboDRUG

physiological serum infusion

Cisatracurium besilateDRUG

Cisatracurium besilate infusion (900mg/day)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (20)

Réanimation polyvalente

Aix-en-Provence, France

Réanimation Polyvalente

Avignon, France

Outcomes

Primary Outcomes

Reduction of the mortality rate of ARDS patients at d90

Time frame: 36 months

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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