Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-28 @ 10:38 AM
Study NCT ID:
NCT01115166
Status:
COMPLETED
Last Update Posted:
2012-10-08
First Post:
2010-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joachim.zdolsek@lio.se', 'phone': '+46101030000', 'title': 'Joachim Zdolsek', 'organization': 'Department of Anaestesilogy and Intensive Care'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The number of patients was small and it was not possible to use a reference method. Standardization was difficult due to the fact that it was a clinical study.'}}, 'adverseEventsModule': {'timeFrame': 'Patients were followed up to 24 hours after CPB. No intervention except additional blood samples was performed, during the CPB.', 'eventGroups': [{'id': 'EG000', 'title': 'Cardiac Surgery', 'description': 'Patients subjected to open cardiac surgery with the help of extracorporal circulation.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Blood Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac Surgery', 'description': 'Patients subjected to open cardiac surgery with the help of extracorporal circulation.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.61', 'spread': '0.86', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after start of CPB', 'description': 'volume kinetic technique: During start of cardio pulmonary by-pass a known amount of fluid will expand the blood volume and dilute the hemoglobin.\n\n1. The hemoglobin variation is used to calculate the blood volume. The last hemoglobin value before CPB and the hemoglobin value directly after start (extrapolated from the following 30 minutes after start) of CPB are used in the calculation.\n2. The value for the blood volume directly prior to CPB will be influenced by intra venous fluids given during early stages of the anesthesia.\n\nTo achieve the blood volume prior to anesthesia a hemoglobin value before anesthesia and the last hemoglobin value before CPB are used to correct the blood volume calculation. In this way blood volume prior to anaesthesia can be calculated.', 'unitOfMeasure': 'Litre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was mainly an observational study, and 10 patients was regarded as a sufficient number to register general changes.'}, {'type': 'SECONDARY', 'title': 'Intracellular Edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac Surgery', 'description': 'Patients subjected to open cardiac surgery with the help of extracorporal circulation.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.557', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after CPB', 'description': 'Mass balance based on repeated Sodium concentration, fluid volume given, given and excreted Sodium.\n\nA positive value indicating intracellular fluid accumulation and a negative value indicating cell dehydration. This is the change that will occur during the first 30 min after start of cardio pulmonary bypass.', 'unitOfMeasure': 'Litre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mainly observational. 10 patients were regarded to be a sufficient number to se a tendency.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fluid Extravasation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac Surgery', 'description': 'Patients subjected to open cardiac surgery with the help of extracorporal circulation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.38', 'spread': '0.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Two distribution half-times. Approximately 16 minutes.', 'description': 'Rate of fluid transfer from the intravascular to the extravascular compartment during two distribution half-times. Graph derived from the hemoglobin change during 20 to 30 minutes after start of cardio pulmonary by-pass.', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was mainly an observational study, and 10 patients was regarded as a sufficient number to register general changes.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cardiac Surgery', 'description': 'Patients subjected to open cardiac surgery with the help of extracorporal circulation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'January 2010 to September 2010 at thoracic surgery department', 'preAssignmentDetails': 'Included patients (10). All participated in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cardiac Surgery', 'description': 'Patients subjected to open cardiac surgery with the help of extracorporal circulation.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.1', 'spread': '11.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-06', 'studyFirstSubmitDate': '2010-05-03', 'resultsFirstSubmitDate': '2012-05-11', 'studyFirstSubmitQcDate': '2010-05-03', 'lastUpdatePostDateStruct': {'date': '2012-10-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-06', 'studyFirstPostDateStruct': {'date': '2010-05-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fluid Extravasation', 'timeFrame': 'Two distribution half-times. Approximately 16 minutes.', 'description': 'Rate of fluid transfer from the intravascular to the extravascular compartment during two distribution half-times. Graph derived from the hemoglobin change during 20 to 30 minutes after start of cardio pulmonary by-pass.'}], 'primaryOutcomes': [{'measure': 'Blood Volume', 'timeFrame': '30 minutes after start of CPB', 'description': 'volume kinetic technique: During start of cardio pulmonary by-pass a known amount of fluid will expand the blood volume and dilute the hemoglobin.\n\n1. The hemoglobin variation is used to calculate the blood volume. The last hemoglobin value before CPB and the hemoglobin value directly after start (extrapolated from the following 30 minutes after start) of CPB are used in the calculation.\n2. The value for the blood volume directly prior to CPB will be influenced by intra venous fluids given during early stages of the anesthesia.\n\nTo achieve the blood volume prior to anesthesia a hemoglobin value before anesthesia and the last hemoglobin value before CPB are used to correct the blood volume calculation. In this way blood volume prior to anaesthesia can be calculated.'}], 'secondaryOutcomes': [{'measure': 'Intracellular Edema', 'timeFrame': '30 minutes after CPB', 'description': 'Mass balance based on repeated Sodium concentration, fluid volume given, given and excreted Sodium.\n\nA positive value indicating intracellular fluid accumulation and a negative value indicating cell dehydration. This is the change that will occur during the first 30 min after start of cardio pulmonary bypass.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['blood volume'], 'conditions': ['Blood Volume, Extravasation']}, 'referencesModule': {'references': [{'pmid': '25141112', 'type': 'DERIVED', 'citation': 'Tornudd M, Hahn RG, Zdolsek JH. Fluid distribution kinetics during cardiopulmonary bypass. Clinics (Sao Paulo). 2014 Aug;69(8):535-41. doi: 10.6061/clinics/2014(08)06.'}]}, 'descriptionModule': {'briefSummary': 'In patients undergoing extracorporal circulation during cardiac operation, the hemoglobin is subjected to large changes. The purpose of this study is to see if it is possible with the help of volume kinetic techniques to use these variations to measure blood volume and fluid escape from the intravascular volume.', 'detailedDescription': 'In many clinical situations, such as extensive surgery, it is of value to determine blood volume and rate of fluid loss from the intravascular space, since hypo- and hypervolemia are combined with increased morbidity and mortality. In this study we which to use the large variations in hemoglobin during extracorporal to calculate both these variables.\n\nHemoglobin is measured every 5 minutes during one hour beginning shortly before start of the heart-lung machine. When the extracorporal circulation begins the hemoglobin decreases due to the quick mix and dilution of the priming fluid from the heart-lung machine with the patients blood.\n\nFrom the amount of priming fluid and the fall of the hemoglobin, the blood volume can be calculated. If no further fluid is given the next 20 to 30 minutes, the hemoglobin concentration will in most cases increase as a result of the fluid loss from the vascular space. This increase in combination with the diureses can be used to calculate the intravascular fluid loss to the interstitium during surgery.\n\nSodium concentration will also be measured in parallel with the hemoglobin concentration.\n\nThe Sodium concentrations in combination with given and excreted (urine)Sodium can be used in a mass balance to calculate if intracellular edema is induced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients subjected to open cardiac surgery, with the help of extracorporal circulation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* open heart surgery, with extracorporal circulation\n* consent to participation'}, 'identificationModule': {'nctId': 'NCT01115166', 'briefTitle': 'Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Linkoeping'}, 'officialTitle': 'Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation', 'orgStudyIdInfo': {'id': 'BVECC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac surgery', 'description': 'Patients subjected to open cardiac surgery with the help of extracorporal circulation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '581 85', 'city': 'Linköping', 'state': 'Linkoeping', 'country': 'Sweden', 'facility': 'University Hospital, Thoracic operation ward', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Joachim Zdolsek, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Linköping, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Joachim Zdolsek', 'investigatorAffiliation': 'University Hospital, Linkoeping'}}}}