Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2026-01-05 @ 6:38 PM
Study NCT ID:
NCT00299650
Status:
COMPLETED
Last Update Posted:
2008-10-10
First Post:
2006-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D009123', 'term': 'Muscle Hypotonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C101584', 'term': 'cisatracurium'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-09', 'studyFirstSubmitDate': '2006-03-06', 'studyFirstSubmitQcDate': '2006-03-06', 'lastUpdatePostDateStruct': {'date': '2008-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of the mortality rate of ARDS patients at d90', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': 'march 2009'}, {'measure': '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', 'timeFrame': 'march 2009'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ARDS', 'mortality', 'mechanical ventilation', 'pneumonia', 'muscle relaxants'], 'conditions': ['ARDS']}, 'referencesModule': {'references': [{'pmid': '27894328', 'type': 'DERIVED', 'citation': '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': '20843245', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ARDS with a PaO2 / FiO2 \\< 150 with a PEEP \\> 5 since less than 48 hrs\n* informed consent\n\nExclusion Criteria:\n\n* NMBA allergy\n* Continuous administration of NMBA for ARDS prior inclusion\n* Age \\< 18 yrs\n* SAPS II \\> 70\n* Persistent air leak'}, 'identificationModule': {'nctId': 'NCT00299650', 'briefTitle': 'Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients', 'orgStudyIdInfo': {'id': 'ACURASYS'}, 'secondaryIdInfos': [{'id': 'PHRC 2004'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: cisatracurium', 'Drug: Cisatracurium besilate']}], 'interventions': [{'name': 'cisatracurium', 'type': 'DRUG', 'armGroupLabels': ['B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'physiological serum infusion', 'armGroupLabels': ['A']}, {'name': 'Cisatracurium besilate', 'type': 'DRUG', 'description': 'Cisatracurium besilate infusion (900mg/day)', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'Réanimation polyvalente', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'city': 'Avignon', 'country': 'France', 'facility': 'Réanimation Polyvalente', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'city': 'Besançon', 'country': 'France', 'facility': 'Hôpital Jean Minjoz - Réanimation médicale', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': 'France', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital Pellegrin - Réanimation médicale', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Brest', 'country': 'France', 'facility': 'Réanimation médicale', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Réanimation chirurgicale', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'Hôpital de la Tronche - Réanimation médicale', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital de la croix rousse - Réanimation médicale', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Ambroise Paré - Réanimation', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Sainte-Marguerite - Réanimation médicale', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Réanimation Polyvalente - Hôpital Sainte-Marguerite', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13015', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Nord - Réanimation', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Réanimation chirurgicale', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nice', 'country': 'France', 'facility': 'Réanimation médicale', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Nîmes', 'country': 'France', 'facility': 'Réanimation chirurgicale', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Nîmes', 'country': 'France', 'facility': 'Réanimation Médicale', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint-Louis - Réanimation médicale', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Hôpital Pontchaillou - Réanimation médicale', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Hôpital Bellevue - Réanimation Médicale', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Toulon', 'country': 'France', 'facility': 'Réanimation polyvalente', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}], 'overallOfficials': [{'name': 'Laurent Papazian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique Hôpitaux de Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Pr PAPAZIAN Laurent', 'oldOrganization': 'ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE'}}}}