Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-04 @ 7:02 AM
Study NCT ID:
NCT00327704
Status:
COMPLETED
Last Update Posted:
2011-04-06
First Post:
2006-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Albumin Resuscitation During Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000418', 'term': 'Albumins'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 794}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-05', 'studyFirstSubmitDate': '2006-05-17', 'studyFirstSubmitQcDate': '2006-05-17', 'lastUpdatePostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality, any cause, during the 28 day period after randomization', 'timeFrame': 'day 28'}], 'secondaryOutcomes': [{'measure': 'Evaluation of sequential organ failure assessment (SOFA) score', 'timeFrame': 'ICU period'}, {'measure': 'catecholamine free days', 'timeFrame': 'day 28'}, {'measure': 'incidence of nosocomial infection', 'timeFrame': 'ICU period'}, {'measure': 'mortality at 90 days', 'timeFrame': 'day 90'}, {'measure': 'length of ICU hospitalisation', 'timeFrame': 'ICU discharge'}, {'measure': 'length of total hospitalisation', 'timeFrame': 'hospital discharge'}]}, 'conditionsModule': {'keywords': ['Septic Shock'], 'conditions': ['Septic Shock']}, 'descriptionModule': {'briefSummary': 'Objective: To determine whether the early administration of albumin as an expander and antioxidant would improve survival on the 28th day for septic shock patients.\n\nDesign: Prospective, multicenter, randomized, controlled versus saline, stratified on nosocomial infection and center.\n\nSetting: 27 Intensive Care Units (ICU) in France\n\nCoordinator: Pr J.P. Mira and Dr J. Charpentier - Cochin Hospital- Paris\n\nPatients: 800 patients could be included during the first 6 hours of their septic shock.', 'detailedDescription': 'The primary outcome: Mortality during the 28 day period after randomization. The secondary outcomes: Evaluation of SOFA score, ventilator-free days, dialysis free days, catecholamine free days, days of hospitalisation, incidence of nosocomial infections.\n\nThe albuminemia of all patients is requested before the treatment until Day 4 post treatment.\n\nThe treatment is: Vialebex 20% 100ml every 8 hours during 3 days versus saline 100ml every 8 hours during 3 days.\n\nThe first patient will be in July 2006, the last patient expected is on July 2009.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years old\n* Septic shock \\< 6 hours\n* Agreement of patients\n\nExclusion Criteria:\n\n* Allergy to albumin\n* Weight \\> 120 kg\n* Non septic shock\n* Burned\n* Cirrhosis\n* Albumin perfusion 48 hours before randomization\n* Pregnant women\n* Cardiac dysfunction New York Heart Association (NYHA) 3 or 4\n* Patients with therapeutic limitation'}, 'identificationModule': {'nctId': 'NCT00327704', 'briefTitle': 'Early Albumin Resuscitation During Septic Shock', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoire français de Fractionnement et de Biotechnologies'}, 'officialTitle': 'Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline', 'orgStudyIdInfo': {'id': 'LFB N°ALBU-0503'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Albumin', 'interventionNames': ['Drug: albumin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'interventionNames': ['Drug: saline']}], 'interventions': [{'name': 'albumin', 'type': 'DRUG', 'otherNames': ['Vialebex'], 'description': 'albumin 20% 100 ml/8 hours for 3 days', 'armGroupLabels': ['Albumin']}, {'name': 'saline', 'type': 'DRUG', 'description': 'saline 100 ml/8hours for 3 days', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75 014', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'Cochin Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jean P Mira, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Cochin Hospital'}, {'name': 'Julien Charpentier, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpital Cochin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoire français de Fractionnement et de Biotechnologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jean-Paul MIRA, Professor', 'oldOrganization': 'Cochin Hospital, Paris France'}}}}