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Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

NCT ID: NCT00299650

Last Updated: 2008-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-10-31

Brief Summary

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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

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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.

Conditions

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ARDS

Keywords

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ARDS mortality mechanical ventilation pneumonia muscle relaxants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

physiological serum infusion

B

Group Type ACTIVE_COMPARATOR

cisatracurium

Intervention Type DRUG

Cisatracurium besilate

Intervention Type DRUG

Cisatracurium besilate infusion (900mg/day)

Interventions

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cisatracurium

Intervention Type DRUG

Placebo

physiological serum infusion

Intervention Type DRUG

Cisatracurium besilate

Cisatracurium besilate infusion (900mg/day)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE

Principal Investigators

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Laurent Papazian, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hôpitaux de Marseille

Locations

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Réanimation polyvalente

Aix-en-Provence, , France

Site Status

Réanimation Polyvalente

Avignon, , France

Site Status

Hôpital Jean Minjoz - Réanimation médicale

Besançon, , France

Site Status

Hôpital Pellegrin - Réanimation médicale

Bordeaux, , France

Site Status

Réanimation médicale

Brest, , France

Site Status

Réanimation chirurgicale

Clermont-Ferrand, , France

Site Status

Hôpital de la Tronche - Réanimation médicale

Grenoble, , France

Site Status

Hôpital de la croix rousse - Réanimation médicale

Lyon, , France

Site Status

Hôpital Ambroise Paré - Réanimation

Marseille, , France

Site Status

Hôpital Sainte-Marguerite - Réanimation médicale

Marseille, , France

Site Status

Réanimation Polyvalente - Hôpital Sainte-Marguerite

Marseille, , France

Site Status

Hôpital Nord - Réanimation

Marseille, , France

Site Status

Réanimation chirurgicale

Montpellier, , France

Site Status

Réanimation médicale

Nice, , France

Site Status

Réanimation chirurgicale

Nîmes, , France

Site Status

Réanimation Médicale

Nîmes, , France

Site Status

Hôpital Saint-Louis - Réanimation médicale

Paris, , France

Site Status

Hôpital Pontchaillou - Réanimation médicale

Rennes, , France

Site Status

Hôpital Bellevue - Réanimation Médicale

Saint-Etienne, , France

Site Status

Réanimation polyvalente

Toulon, , France

Site Status

Countries

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France

References

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Guerin C, Papazian L, Reignier J, Ayzac L, Loundou A, Forel JM; investigators of the Acurasys and Proseva trials. Effect of driving pressure on mortality in ARDS patients during lung protective mechanical ventilation in two randomized controlled trials. Crit Care. 2016 Nov 29;20(1):384. doi: 10.1186/s13054-016-1556-2.

Reference Type DERIVED
PMID: 27894328 (View on PubMed)

Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.

Reference Type DERIVED
PMID: 20843245 (View on PubMed)

Other Identifiers

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PHRC 2004

Identifier Type: -

Identifier Source: secondary_id

ACURASYS

Identifier Type: -

Identifier Source: org_study_id