ARDSPhase 4NCT00299650
Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients
A Phase 4 study testing cisatracurium and Cisatracurium besilate in people with ARDS, run by Assistance Publique Hopitaux De Marseille at 20 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ARDS
- What is being tested?
- cisatracurium and Cisatracurium besilate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 20 sitesFrance
- Study dates
- Mar 2006to Oct 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ARDS with a PaO2 / FiO2 < 150 with a PEEP > 5 since less than 48 hrs
- informed consent
Who cannot join
- NMBA allergy
- Continuous administration of NMBA for ARDS prior inclusion
- Age < 18 yrs
- SAPS II > 70
- Persistent air leak
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
Réanimation polyvalente
Aix-en-Provence
Réanimation Polyvalente
Avignon
Hôpital Jean Minjoz - Réanimation médicale
Besançon
Hôpital Pellegrin - Réanimation médicale
Bordeaux, France
Réanimation médicale
Brest
Réanimation chirurgicale
Clermont-Ferrand
Hôpital de la Tronche - Réanimation médicale
Grenoble
Hôpital de la croix rousse - Réanimation médicale
Lyon
Hôpital Ambroise Paré - Réanimation
Marseille, 13000
Hôpital Sainte-Marguerite - Réanimation médicale
Marseille, 13009
Réanimation Polyvalente - Hôpital Sainte-Marguerite
Marseille, 13009
Hôpital Nord - Réanimation
Marseille, 13015
Réanimation chirurgicale
Montpellier
Réanimation médicale
Nice
Réanimation chirurgicale
Nîmes
Réanimation Médicale
Nîmes
Hôpital Saint-Louis - Réanimation médicale
Paris
Hôpital Pontchaillou - Réanimation médicale
Rennes
Hôpital Bellevue - Réanimation Médicale
Saint-Etienne
Réanimation polyvalente
Toulon
About this study
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.
Read the 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.
- Conditions
- ARDS
- Being tested
- cisatracurium, Placebo, Cisatracurium besilate
- Keywords
- ARDS, mortality, mechanical ventilation, pneumonia, muscle relaxants
- Medical subject headings
- Pneumonia, Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisatracuriumDrug
PlaceboDrug
physiological serum infusion
Cisatracurium besilateDrug
Cisatracurium besilate infusion (900mg/day)
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: Placebo |
| B | Active comparator | Not described Receives: Drug: cisatracurium; Drug: Cisatracurium besilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the mortality rate of ARDS patients at d90
Measured: 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
Measured: 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
Measured: march 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Laurent Papazian, MD, Principal investigator, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299650
- Sponsor's protocol ID
- ACURASYS
- Other IDs
- PHRC 2004
- Status last verified
- Oct 2008
- First submitted
- 6 Mar 2006
- Last updated
- 10 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27894328Papazian 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.
PubMed 20843245
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients
- ClinicalTrials.gov ID
- NCT00299650
- Acronym / sponsor ID
- ACURASYS
- Conditions
- ARDS
- Keywords
- ARDS, mortality, mechanical ventilation, pneumonia, muscle relaxants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 7 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Placebo |
| B | Active comparator | Drug: cisatracurium, Drug: Cisatracurium besilate |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ARDS with a PaO2 / FiO2 < 150 with a PEEP > 5 since less than 48 hrs
- informed consent
Key exclusion criteria (5 listed)
- NMBA allergy
- Continuous administration of NMBA for ARDS prior inclusion
- Age < 18 yrs
- SAPS II > 70
- Persistent air leak
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisatracurium | Drug | B |
| Placebophysiological serum infusion | Drug | A |
| Cisatracurium besilateCisatracurium besilate infusion (900mg/day) | Drug | B |
Primary outcome
Reduction of the mortality rate of ARDS patients at d90
Time frame: 36 months
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2008.
- Derived from this study: PubMed 27894328Guerin 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.
- Derived from this study: PubMed 20843245Papazian 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.
Related trials for ARDS
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Papazian, MD principal investigator
Assistance Publique Hôpitaux de Marseille
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cisatracurium and Cisatracurium besilate in people with ARDS, run by Assistance Publique Hopitaux De Marseille at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of the mortality rate of ARDS patients at d90 (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00299650, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2008.