Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-29 @ 3:00 PM
Study NCT ID:
NCT04388995
Status:
UNKNOWN
Last Update Posted:
2020-08-26
First Post:
2020-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-25', 'studyFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2020-05-13', 'lastUpdatePostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fluid responsiveness', 'timeFrame': 'immediately after the fluid therapy', 'description': 'Fluid responsiveness was defined as an increase in CI ≥15%'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke Volume Variation', 'Pulse Pressure Variation', 'Fluid Responsiveness', 'Fluid Therapy']}, 'descriptionModule': {'briefSummary': 'Although individualized or goal-directed approach has been advocated, a reliable index is still required to help monitor the volume status timely and efficiently. Dynamic indexes, such as pulse pressure variation (PPV) and stroke volume variation (SVV), have been shown to be clearly superior to more commonly measured static preload variables, such as pulmonary artery occlusion pressure (PAOP) and central venous pressure (CVP). The reliability of dynamic indexes in monitoring the volume status and predicting fluid responsiveness have been validated. Fluid optimization guided by SVV and PPV is beneficial to hemodynamic stability and can decrease mortality and reduce postoperative complications. However, the usefulness of dynamic indexes in elderly patients has not been previously investigated. This study aimed to evaluate whether dynamic indexes PPV and SVV can reliably predict fluid responsiveness in elderly patients, and to determine their thresholds in elderly patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Patients undergoing gastrointestinal surgery 2.Age between 18 and 80 3.ASA I \\~II. 4.BMI 18 \\~ 24 kg/m2\n\nExclusion Criteria:\n\n* 1.arrhythmias 2.intracardiac shunts 3.severe hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) 4.pulmonary hypertension 5.chronic obstructive pulmonary disease 6.peripheral vascular obstructive disease 7.receiving long-term treatment with vasopressors.'}, 'identificationModule': {'nctId': 'NCT04388995', 'briefTitle': 'SVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Stroke Volume Variation and Pulse Pressure Variation Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia', 'orgStudyIdInfo': {'id': 'PLAGHAOC202002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'observed patients', 'interventionNames': ['Diagnostic Test: volume expansion']}], 'interventions': [{'name': 'volume expansion', 'type': 'DIAGNOSTIC_TEST', 'description': 'volume expansion with 6% hydroxyethyl starch (7 mL/kg) at a rate of 0.4 mL/kg/min', 'armGroupLabels': ['observed patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Haidian', 'country': 'China', 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yi Liu', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}