Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-01 @ 10:11 AM
Study NCT ID:
NCT02757118
Status:
UNKNOWN
Last Update Posted:
2016-04-29
First Post:
2016-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity for Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-27', 'studyFirstSubmitDate': '2016-04-27', 'studyFirstSubmitQcDate': '2016-04-27', 'lastUpdatePostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'whole blood viscosity', 'timeFrame': 'with 1 hour after the completion of procedure'}], 'secondaryOutcomes': [{'measure': 'PaO2/FiO2 ratio', 'timeFrame': 'with 1 hour after the completion of procedure', 'description': 'PaO2/FiO2 ratio measured by arterial blood gas analysis'}, {'measure': 'hematocrit', 'timeFrame': 'with 1 hour after the completion of procedure', 'description': 'serum hematocrit, %'}, {'measure': 'glucose', 'timeFrame': 'with 1 hour after the completion of procedure', 'description': 'serum glucose level, g/dl'}, {'measure': 'osmolarity', 'timeFrame': 'with 1 hour after the completion of procedure', 'description': 'serum osmolarity, mOsm'}, {'measure': 'urine output', 'timeFrame': 'with 1 hour after the completion of procedure', 'description': 'hourly urine output, ml/hr'}, {'measure': 'Maximum clot formation', 'timeFrame': 'with 1 hour after the completion of procedure', 'description': 'Maximum clot formation in rotational thromboelastometry (ROTEM) analysis, mm'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac Surgery, blood viscosity'], 'conditions': ['Cardiac Surgery']}, 'descriptionModule': {'briefSummary': "After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing cardiac surgery are enrolled in this prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES (n=15).\n\nAll recruited patients will be given patient identification number (PIN) for the present study of 01-30 according to their order of interview and recruitment. Investigators will prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30 (Envelop number). After printing the envelope number outside envelope, all sealed envelopes with cards will be conveyed to and kept in pharmacy department.\n\nAccording to the color of the card, attending anesthesiologists will give crystalloid for yellow card or HES for green cards, respectively, to maintain stroke volume variation \\< 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.\n\nPatient data and statistical analyses:\n\nPatient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be determined from the patients' medical record after patient's discharge.\n\nAll statistical analyses will be performed after the 30th patient's discharge and data acquisition"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing coiling embolization procedure due to cardiac surgery\n* Patients provided a written informed consent.\n* Patients with preoperative serum hemoglobin concentration \\>13 g/dL (male) and \\>12 g/dL (female)\n* Patients with PaO2/FiO2 ratio \\>150\n\nExclusion Criteria:\n\n* Patients with history of anemia, dyspnea, active infection.\n* Patients with endocrine disease\n* Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-platelet drug, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing cardiac surgery.'}, 'identificationModule': {'nctId': 'NCT02757118', 'briefTitle': 'Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity for Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Konkuk University Medical Center'}, 'officialTitle': 'Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During Cardiac Surgery', 'orgStudyIdInfo': {'id': 'KUH000011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Intravenous Crystalloid', 'description': 'crystalloid is administered to maintain stroke volume variation \\< 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture', 'interventionNames': ['Drug: Intravenous Crystalloid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous HES', 'description': 'HES is administered to maintain stroke volume variation \\< 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture', 'interventionNames': ['Drug: Intravenous HES']}], 'interventions': [{'name': 'Intravenous Crystalloid', 'type': 'DRUG', 'description': 'crystalloid is administered to maintain stroke volume variation \\< 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture', 'armGroupLabels': ['Intravenous Crystalloid']}, {'name': 'Intravenous HES', 'type': 'DRUG', 'description': 'HES is administered to maintain stroke volume variation \\< 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture', 'armGroupLabels': ['Intravenous HES']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tae-Yop Kim, MD, PhD', 'role': 'CONTACT', 'email': 'taeyop@gmail.com', 'phone': '82-2-2030-5448'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Tae-Yop Kim, MD PhD', 'investigatorAffiliation': 'Konkuk University Medical Center'}}}}