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Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00299650
Enrollment
340
Registered
2006-03-07
Start date
2006-03-31
Completion date
2008-10-31
Last updated
2008-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS

Keywords

ARDS, mortality, mechanical ventilation, pneumonia, muscle relaxants

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.

Interventions

DRUGcisatracurium
DRUGPlacebo

physiological serum infusion

Cisatracurium besilate infusion (900mg/day)

Sponsors

GlaxoSmithKline
CollaboratorINDUSTRY
Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Reduction of the mortality rate of ARDS patients at d9036 months

Secondary

MeasureTime frame
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 daysmarch 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 180march 2009

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026