NCT00299650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2006

Typical duration for phase_4

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

October 10, 2008

Status Verified

October 1, 2008

Enrollment Period

2.6 years

First QC Date

March 6, 2006

Last Update Submit

October 9, 2008

Conditions

ARDS

Keywords

ARDSmortalitymechanical ventilationpneumoniamuscle relaxants

Outcome Measures

Primary Outcomes (1)

  • Reduction of the mortality rate of ARDS patients at d90

    36 months

Secondary Outcomes (2)

  • 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

    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

    march 2009

Study Arms (2)

A

PLACEBO COMPARATOR
Drug: Placebo

B

ACTIVE COMPARATOR
Drug: cisatracuriumDrug: Cisatracurium besilate

Interventions

cisatracuriumDRUG
B
PlaceboDRUG

physiological serum infusion

A
Cisatracurium besilateDRUG

Cisatracurium besilate infusion (900mg/day)

B

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ARDS with a PaO2 / FiO2 \< 150 with a PEEP \> 5 since less than 48 hrs
  • informed consent

You may not qualify if:

  • NMBA allergy
  • Age \< 18 yrs
  • SAPS II \> 70
  • Persistent air leak

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Réanimation polyvalente

Aix-en-Provence, France

Location

Réanimation Polyvalente

Avignon, France

Location

Hôpital Jean Minjoz - Réanimation médicale

Besançon, France

Location

Hôpital Pellegrin - Réanimation médicale

Bordeaux, France, France

Location

Réanimation médicale

Brest, France

Location

Réanimation chirurgicale

Clermont-Ferrand, France

Location

Hôpital de la Tronche - Réanimation médicale

Grenoble, France

Location

Hôpital de la croix rousse - Réanimation médicale

Lyon, France

Location

Hôpital Ambroise Paré - Réanimation

Marseille, 13000, France

Location

Hôpital Sainte-Marguerite - Réanimation médicale

Marseille, 13009, France

Location

Réanimation Polyvalente - Hôpital Sainte-Marguerite

Marseille, 13009, France

Location

Hôpital Nord - Réanimation

Marseille, 13015, France

Location

Réanimation chirurgicale

Montpellier, France

Location

Réanimation médicale

Nice, France

Location

Réanimation chirurgicale

Nîmes, France

Location

Réanimation Médicale

Nîmes, France

Location

Hôpital Saint-Louis - Réanimation médicale

Paris, France

Location

Hôpital Pontchaillou - Réanimation médicale

Rennes, France

Location

Hôpital Bellevue - Réanimation Médicale

Saint-Etienne, France

Location

Réanimation polyvalente

Toulon, France

Location

Related Publications (2)

  • 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.

    PMID: 27894328DERIVED

  • 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.

    PMID: 20843245DERIVED

MeSH Terms

Conditions

PneumoniaMuscle Hypotonia

Interventions

cisatracurium

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Laurent Papazian, MD

    Assistance Publique Hôpitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 6, 2006

First Posted

March 7, 2006

Study Start

March 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

October 10, 2008

Record last verified: 2008-10

Locations

FR(20)