Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-02-20 @ 1:41 PM
Study NCT ID:
NCT01239966
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2010-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary And Renal Support During Acute Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017582', 'term': 'Renal Replacement Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-21', 'studyFirstSubmitDate': '2010-11-12', 'studyFirstSubmitQcDate': '2010-11-12', 'lastUpdatePostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arterial carbon dioxide reduction', 'timeFrame': '20 min', 'description': '20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT'}], 'secondaryOutcomes': [{'measure': 'Gas transfer measurement', 'timeFrame': '20 min, H1, H6, H12, H24, H36, H48 and H72.', 'description': 'Measurement of PO2 and PCO2 before and after the membrane oxygenation'}, {'measure': 'Arterial blood gases', 'timeFrame': '20 min, H1, H6, H12, H24, H36, H48 and H72.', 'description': 'Measurement of arterial blood gases'}, {'measure': 'carbon dioxide elimination (VCO2)', 'timeFrame': '20 min, H1, H6, H12, H24, H36, H48 and H72.', 'description': 'Measurement of carbon dioxide elimination rate at the ventilator and at the membrane oxygenator'}, {'measure': 'Respiratory mechanics and hemodynamic parameters', 'timeFrame': '20 min, H1, H6, H12, H24, H36, H48 and H72.', 'description': 'Measurement of respiratory mechanics and hemodynamic parameters'}, {'measure': 'Safety monitoring', 'timeFrame': '20 min, H1, H6, H12, H24, H36, H48 and H72.', 'description': "Continuous measurement of the differential pressure across the oxygenator membrane and across the hemofilter.\n\nAssessment of catheter dysfunction, clotting or disruption of the extra-corporeal circuit, clotting of the oxygenator membrane or of the hemofilter.\n\nAssessment of patient's haemorragic or thrombotic complications."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Respiratory Distress syndrome', 'Acute renal Failure'], 'conditions': ['Acute Respiratory Distress Syndrome', 'Acute Renal Failure']}, 'referencesModule': {'references': [{'pmid': '17038660', 'type': 'BACKGROUND', 'citation': 'Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. doi: 10.1164/rccm.200607-915OC. Epub 2006 Oct 12.'}, {'pmid': '19741487', 'type': 'RESULT', 'citation': 'Terragni PP, Del Sorbo L, Mascia L, Urbino R, Martin EL, Birocco A, Faggiano C, Quintel M, Gattinoni L, Ranieri VM. Tidal volume lower than 6 ml/kg enhances lung protection: role of extracorporeal carbon dioxide removal. Anesthesiology. 2009 Oct;111(4):826-35. doi: 10.1097/ALN.0b013e3181b764d2.'}], 'seeAlsoLinks': [{'url': 'http://www.hopitaux-ambroisepare-desbief.com/', 'label': 'information related to hospitals and investigators involved'}]}, 'descriptionModule': {'briefSummary': 'In patients presenting with the acute respiratory distress syndrome (ARDS), mechanical ventilation with low tidal volume (6 ml/kg predicted body weight) is the current gold standard for supportive care. However, despite a relative low tidal volume, approximatively one third of patients will experienced tidal hyperinflation, a phenomenon known to induce pulmonary and systemic inflammatory response. A further reduction of the tidal volume to 4 ml/kg (PBW) will prevent pulmonary area from tidal hyperinflation. As a result, hypercarbia and respiratory acidosis are commonly observed with such very low tidal ventilation. Extra corporeal CO2 removal is one of a mean to normalize arterial CO2 tension.\n\nPatients with ARDS also frequently develop acute renal failure which may required Renal Replacement Therapy. Some data suggests that starting early the RRT may favor outcome.\n\nThe investigators hypothesized that a strategy combining ECCOR and RRT early in the course of patients presenting ARDS and acute renal failure will allow the tidal volume to be further reduced, providing lung protection, while avoiding the arterial CO2 tension to be increased.\n\nFor this purpose, the investigators sought to evaluate the safety and efficacy of adding a membranel oxygenator within an hemofiltration circuit, either upstream or downstream of the hemofilter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute Respiratory Distress Syndrome according to the AECC definition\n* Acute Renal Failure according to the RIFLE definition\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* PaO2/FiO2 \\< 100 with FIO2 = 1 and PEEP \\> 18 cmH2O\n* DNR order or death expected within the next 3 days\n* Intracranial haemorrhage or hypertension\n* Heparin allergy'}, 'identificationModule': {'nctId': 'NCT01239966', 'acronym': 'PARSA', 'briefTitle': 'Pulmonary And Renal Support During Acute Respiratory Distress Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Européen Marseille'}, 'officialTitle': 'Safety and Efficacy of Combined Extracorporeal CO2 Removal and Renal Replacement Therapy in Patients With the Acute Respiratory Distress Syndrome and Acute Renal Failure', 'orgStudyIdInfo': {'id': '2010-A00397-32'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Combined ECCOR and RRT', 'type': 'DEVICE', 'description': 'Insertion of a membrane oxygenator (Hilite 2400 LT, Medos, Germany) within an hemofilter circuit (M150,PrismaFlex, Hospal); either upstream or downstream of the hemofilter.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13002', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Paul Desbief', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13006', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Ambroise Pare', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Jérôme Allardet-Servent, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Ambroise Pare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Européen Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSc', 'investigatorFullName': 'Jerome Allardet-Servent, MD', 'investigatorAffiliation': 'Hôpital Européen Marseille'}}}}