Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-01-06 @ 1:13 AM
Study NCT ID:
NCT02288494
Status:
UNKNOWN
Last Update Posted:
2014-11-11
First Post:
2014-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acid Base Balance of ICU Patients With Severe Hypoalbuminemia, Before and After an Albumin Infusion, Using Stewart Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034141', 'term': 'Hypoalbuminemia'}], 'ancestors': [{'id': 'D007019', 'term': 'Hypoproteinemia'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-07', 'studyFirstSubmitDate': '2014-09-12', 'studyFirstSubmitQcDate': '2014-11-07', 'lastUpdatePostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in pH and independent pH determinants using Stewart approach', 'timeFrame': 'at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.'}], 'secondaryOutcomes': [{'measure': 'changes in neurologic parameters', 'timeFrame': 'at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.'}, {'measure': 'changes in hemodynamic parameters', 'timeFrame': 'at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.'}, {'measure': 'changes in respiratory parameters', 'timeFrame': 'at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.'}]}, 'conditionsModule': {'keywords': ['hypoalbuminemia', '-acid base balance', 'acid base disorders', 'critical ill', 'Stewart approach', 'human albumin infusion'], 'conditions': ['Hypoalbuminemia', 'Adult ICU Patient', 'Stewart Approach for Acid Base Disorders', 'Human Albumin Perfusion']}, 'descriptionModule': {'briefSummary': "The primary purpose was to describe the acid base balance of ICU patients with severe hypoalbuminemia using Stewart's approach for acid base disorders, before and after an human albumin perfusion.", 'detailedDescription': 'Prospective study, for ICU patient with severe hypoalbuminemia \\< 20g/L, determining biological parameters from Stewart approach for acid base disorders (pH, SIDe, SIDa, SIG, Atot, PaCO2) before, and at 1hour, 2hours and 24 hours after a 200mL 20% human albumin perfusion (the consensus conference ANAES of 1995 recommands to correct hypoalbuminemia below 20g/L).\n\nClinical parameters (respiratory, haemodynamic, neurologic) were also collected at the same times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ICU patients with severe hypoalbuminemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* serum albuminemia \\< 20g/L\n* adult ICU patient\n* Arterial line\n\nExclusion Criteria:\n\n* albumin allergy\n* pregnancy\n* congestive heart failure'}, 'identificationModule': {'nctId': 'NCT02288494', 'acronym': 'STEWALB', 'briefTitle': 'Acid Base Balance of ICU Patients With Severe Hypoalbuminemia, Before and After an Albumin Infusion, Using Stewart Approach', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Acid Base Balance of ICU Patients With Severe Hypoalbuminemia, Before and After an Albumin Infusion, Using Stewart Approach', 'orgStudyIdInfo': {'id': 'CHU-0204'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hypoalbuminemia', 'description': "The primary purpose was to describe the acid base balance of ICU patients with severe hypoalbuminemia using Stewart's approach for acid base disorders, before and after an human albumin perfusion", 'interventionNames': ['Other: stewart approach']}], 'interventions': [{'name': 'stewart approach', 'type': 'OTHER', 'description': 'Prospective study, for ICU patient with severe hypoalbuminemia \\< 20g/L, determining biological parameters from Stewart approach for acid base disorders (pH, SIDe, SIDa, SIG, Atot, PaCO2) before, and at 1hour, 2hours and 24 hours after a 200mL 20% human al Clinical parameters (respiratory, haemodynamic, neurologic) were also collected at the same times.', 'armGroupLabels': ['hypoalbuminemia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Julien PASCAL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}