Ignite Creation Date:
2025-12-24 @ 12:45 PM
Ignite Modification Date:
2025-12-29 @ 12:20 PM
Study NCT ID:
NCT04934761
Status:
COMPLETED
Last Update Posted:
2021-06-22
First Post:
2021-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Effect of Capacity Shock Intervention Under Goal-directed Hemodynamic Management on P-V Loop
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-19', 'studyFirstSubmitDate': '2021-05-25', 'studyFirstSubmitQcDate': '2021-06-19', 'lastUpdatePostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ees', 'timeFrame': 'Baseline，After induction', 'description': 'Ees（End-systole Elasticity，mmHg/ml）'}, {'measure': 'Ees', 'timeFrame': 'Immediately after the intervention,complete of the first round of the fluid challenge', 'description': 'Ees（End-systole Elasticity，mmHg/ml）'}, {'measure': 'Ees', 'timeFrame': 'Immediately after the intervention,complete of the second round of the fluid challenge', 'description': 'Arterial elasticity is an invasively determined parameter of arterial load that is inversely related to arterial compliance'}, {'measure': 'Ees', 'timeFrame': '1h after the first fluid challenge', 'description': 'Ees（End-systole Elasticity，mmHg/ml）'}, {'measure': 'Ees', 'timeFrame': 'At the end of surgery', 'description': 'Ees（End-systole Elasticity，mmHg/ml）'}, {'measure': 'SW', 'timeFrame': 'Baseline，after induction', 'description': 'SW（Stroke Volume，mmHg·ml）'}, {'measure': 'SW', 'timeFrame': 'Immediately after the intervention,complete of the first round of the fluid challenge', 'description': 'SW（Stroke Volume，mmHg·ml）'}, {'measure': 'SW', 'timeFrame': 'Immediately after the intervention,complete of the second round of the fluid challenge', 'description': 'SW（Stroke Volume，mmHg·ml）'}, {'measure': 'SW', 'timeFrame': '1h after the first fluid challenge', 'description': 'SW（Stroke Volume，mmHg·ml）'}, {'measure': 'SW', 'timeFrame': 'At the end of surgery', 'description': 'SW（Stroke Volume，mmHg·ml）'}, {'measure': 'Ea', 'timeFrame': 'Baseline，after induction', 'description': 'Ea(Arterial elasticity, mmHg·ml)'}, {'measure': 'Ea', 'timeFrame': 'Immediately after the intervention,complete of the first round of the fluid challenge', 'description': 'Ea(Arterial elasticity, mmHg·ml)'}, {'measure': 'Ea', 'timeFrame': 'Immediately after the intervention,complete of the second round of the fluid challenge', 'description': 'Ea(Arterial elasticity, mmHg·ml)'}, {'measure': 'Ea', 'timeFrame': '1h after the first fluid challenge', 'description': 'Ea(Arterial elasticity, mmHg·ml)'}, {'measure': 'Ea', 'timeFrame': 'At the end of surgery', 'description': 'Ea(Arterial elasticity, mmHg·ml)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemodynamics']}, 'descriptionModule': {'briefSummary': 'By observing the changes of P-V loop in capacity shock intervention Under Goal-directed Hemodynamic Management in patients undergoing total knee replacement, we investigate the effect of capacity shock on cardiac contractility and work in order to seek a more effective target plan of capacity shock for intraoperative patients.', 'detailedDescription': "Objective:By observing the changes of P-V loop in capacity shock intervention Under Goal-directed Hemodynamic Management in patients undergoing total knee replacement, we investigate the effect of capacity shock on cardiac contractility and work in order to seek a more effective target plan of capacity shock for intraoperative patients.\n\nMethods:20 patients with total knee replacement were enrolled in this study. Capacity shock therapy was used in Group A(n=10) and conventional strategy was used in Group B (n=10). V(t) was measured and calculated using TEE and P(t) was acquired by the analysis of patients'radial artery pressure waveform. We set five time points of parameter acquisition: after grouping (T1), the first shock completion(T2), the second shock completion (T3), 1h after shock treatment (T4), and operation completion(T5). We make up the P-V loop fitting P(t) and V(t) at each time point after the calibration of cardiac cycle."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nASAI-II age 40- 70 weight 48 - 72 kg.\n\nExclusion Criteria:\n\nBody mass index \\>30 or \\<15 kg/m2 Valve heart disease Left ventricular ejection fraction (LVEF) is less than 50% History of lung disease Preoperative arrhythmic disorder Permanent pacemaker Need for mechanical heart Support, Severe extrinsic vascular disease Valve dysfunction OED monitoring probe insertion contraindications Patients with preoperative assessments'}, 'identificationModule': {'nctId': 'NCT04934761', 'briefTitle': 'Study on the Effect of Capacity Shock Intervention Under Goal-directed Hemodynamic Management on P-V Loop', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou Red Cross Hospital'}, 'officialTitle': 'Study on the Effect of Capacity Shock Intervention Under Goal-directed Hemodynamic Management on P-V Loop-based Myocardial Contraction and Work', 'orgStudyIdInfo': {'id': '202103000022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'capacity shock', 'description': '2ml/kg succinylateol gelatin', 'interventionNames': ['Procedure: Fluid challenge strategy']}, {'type': 'OTHER', 'label': 'routine management', 'description': 'conventional strategy', 'interventionNames': ['Procedure: conventional strategy']}], 'interventions': [{'name': 'Fluid challenge strategy', 'type': 'PROCEDURE', 'description': 'Patients received 2ml/kg of succinylateol gelatin within 10 min for fluid shock therapy after grouping, taking SVV as the management target. If SVV\\< 13% after shock therapy, the shock therapy was stopped and the infusion was maintained with 4ml/kg/h of crystal solution. If SVV ≥ 13% and ΔSV \\<10%, the individual would be excluded from the experiment. If SVV ≥ 13% but ΔSV≥10%, 2ml/kg of succinylateol gelatin was given again within 10 min for liquid shock therapy until SVV\\<13%, and 4ml/kg/h of crystal solution was maintained after reaching the target. If SVV≥ 13% after two shock treatments, they were excluded from the experiment. We excluded patients whose intraoperative bleeding ≥400ml and operative time ≥5 hours from the group.', 'armGroupLabels': ['capacity shock']}, {'name': 'conventional strategy', 'type': 'PROCEDURE', 'description': '4ml/kg/h of crystal solution was maintained. We excluded patients whose intraoperative bleeding ≥400ml and operative time ≥5 hours from the group.', 'armGroupLabels': ['routine management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510220', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangzhou Red cross hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Cao Yang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guangzhou Red Cross Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Red Cross Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of Anesthesiology Physicians', 'investigatorFullName': 'Liang Bing', 'investigatorAffiliation': 'Guangzhou Red Cross Hospital'}}}}