Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

October 9, 2008 updated by: Assistance Publique Hopitaux De Marseille
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

340

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix en Provence, France
        • Réanimation Polyvalente
      • Avignon, France
        • Réanimation Polyvalente
      • Besancon, France
        • Hôpital Jean Minjoz - Réanimation médicale
      • Bordeaux, France, France
        • Hôpital Pellegrin - Réanimation médicale
      • Brest, France
        • Réanimation médicale
      • Clermont-Ferrand, France
        • Réanimation Chirurgicale
      • Grenoble, France
        • Hôpital de la Tronche - Réanimation médicale
      • Lyon, France
        • Hôpital de la croix rousse - Réanimation médicale
      • Marseille, France, 13000
        • Hôpital Ambroise Paré - Réanimation
      • Marseille, France, 13009
        • Hôpital Sainte-Marguerite - Réanimation médicale
      • Marseille, France, 13009
        • Réanimation Polyvalente - Hôpital Sainte-Marguerite
      • Marseille, France, 13015
        • Hôpital Nord - Réanimation
      • Montpellier, France
        • Réanimation Chirurgicale
      • Nice, France
        • Réanimation médicale
      • Nimes, France
        • Réanimation Chirurgicale
      • Nimes, France
        • Réanimation médicale
      • Paris, France
        • Hôpital Saint-Louis - Réanimation médicale
      • Rennes, France
        • Hôpital Pontchaillou - Réanimation médicale
      • Saint-Etienne, France
        • Hôpital Bellevue - Réanimation Médicale
      • Toulon, France
        • Réanimation Polyvalente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Drug: cisatracurium
Drug: Cisatracurium besilate
Cisatracurium besilate infusion (900mg/day)
Placebo Comparator: A
Drug: Placebo
physiological serum infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of the mortality rate of ARDS patients at d90
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time 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 days
Time Frame: march 2009
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
march 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Laurent Papazian, MD, Assistance Publique Hopitaux de Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

March 6, 2006

First Submitted That Met QC Criteria

March 6, 2006

First Posted (Estimate)

March 7, 2006

Study Record Updates

Last Update Posted (Estimate)

October 10, 2008

Last Update Submitted That Met QC Criteria

October 9, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACURASYS
  • PHRC 2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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