Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT02237716
Status:
UNKNOWN
Last Update Posted:
2014-09-11
First Post:
2014-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rapid Intravenous Infusion of Mannitol Results in a Dipper-type Change in Stroke Volume Variation in Patients Undergoing Major Neurosurgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-10', 'studyFirstSubmitDate': '2014-08-26', 'studyFirstSubmitQcDate': '2014-09-10', 'lastUpdatePostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiac index', 'timeFrame': 'during the procedure'}, {'measure': 'stroke volume index', 'timeFrame': 'during the procedure'}, {'measure': 'stroke volume variation', 'timeFrame': 'during the procedure'}, {'measure': 'systolic pressure', 'timeFrame': 'during the procedure'}, {'measure': 'central venous pressure', 'timeFrame': 'during the procedure'}, {'measure': 'heart rate', 'timeFrame': 'during the procedure'}, {'measure': 'peripheral vascular resistance', 'timeFrame': 'during the procedure'}], 'secondaryOutcomes': [{'measure': 'base excess', 'timeFrame': 'during the procedure'}, {'measure': 'lactic acid', 'timeFrame': 'during the procedure'}, {'measure': 'DO2I', 'timeFrame': 'during the procedure'}]}, 'conditionsModule': {'conditions': ['Craniotomy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to observe the variation of Hemodynamics、lactic acid、base excess、peripheral vascular resistance and DO2 through FloTrac™/Vigileo™ system after rapid infusion mannitol in neurosurgery.The hemodynamic changes after mannitol infusion are shown in Figure 1. HR (Fig. 1A) and systolic BP (Figure 1B) significantly increased between 0 min and 10 min (P = 0.041) and between -10 min and 10 min (P = 0.073), respectively; these two variables decreased steadily and returned to the baseline. Diastolic BP (Fig. 1B) showed no significant change after mannitol infusion (P = 0.102). CVP (Fig. 1C) significantly increased between -20 min and 0 min (P \\< 0.001) and constantly decreased after 0 min, which remained below the baseline between 30 min and 60 min. CI (Fig. 1D) and SVI (Fig. 1E) showed a significant persistent increase between -20 min to 0 min (P \\< 0.001) and between -20 min and 10 min (P \\< 0.001), respectively. SVV exhibited a dipper-type change shown as a significant decrease between -20 min and 0 min and a significant increase between 0 min and 60 min (P \\< 0.001), which returned to the baseline after 20 min.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'scheduled for elective craniotomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria were: being aged between 16 and 70 years;\n* with a body mass index of 18-25 kg/m2;\n* with a physical status classified as ASA class I or II;\n* and scheduled for elective craniotomy\n\nExclusion Criteria:\n\n* Any patient would be excluded from this study if the patient had complicating serious coagulopathy, hepatorenal insufficiency, aortic regurgitation, or cardiac arrhythmia;\n* had a previous history of intra-aortic balloon counterpulsation;\n* exhibited systolic blood pressure (SBP) ≥160 mmHg, diastolic blood pressure (DBP) ≥100 mmHg, or heart rate ≥ 100 bpm on operating room admission;\n* or rejected to participate in this study.'}, 'identificationModule': {'nctId': 'NCT02237716', 'briefTitle': 'Rapid Intravenous Infusion of Mannitol Results in a Dipper-type Change in Stroke Volume Variation in Patients Undergoing Major Neurosurgery', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'orgStudyIdInfo': {'id': 'MN2014'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Xinxin Shao', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}