Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-26 @ 12:37 AM
Study NCT ID:
NCT03499860
Status:
COMPLETED
Last Update Posted:
2019-07-22
First Post:
2018-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prediction of Fluid Responsiveness From Passive Leg Raising Induced Changes in Perfusion Index and Pleth Variability Index
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': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-18', 'studyFirstSubmitDate': '2018-03-31', 'studyFirstSubmitQcDate': '2018-04-13', 'lastUpdatePostDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PI difference', 'timeFrame': '90 seconds', 'description': 'Difference in the change of perfusion index from baseline during a passive leg raising maneuver in fluid responsive patients compared to fluid non-responders'}, {'measure': 'PVI difference', 'timeFrame': '90 seconds', 'description': 'Difference in the change of pleth variability index from baseline during a passive leg raising maneuver in fluid responsive patients compared to fluid non-responders'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fluid Responsiveness']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate whether changes in Perfusion Index (PI) and Pleth Variability Index (PVI) during passive leg raising test can predict fluid responsiveness in spontaneously breathing patients.\n\nFluid responsive patients are defined as showing an increase in cardiac output \\>10% during a passive leg raising test, measured semi-invaseively with FloTrac® (Edwards LifeSciences. Irvine, United States).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients admitted to the intensive or intermediate care unit after abdominal surgery (including urological and gynecological surgery performed in laparotomy)\n* Spontaneous breathing\n* Arterial line already in place\n* Oral and written informed consent obtained\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Abdominal trauma as the reason for surgery\n* Missing informed consent'}, 'identificationModule': {'nctId': 'NCT03499860', 'briefTitle': 'Prediction of Fluid Responsiveness From Passive Leg Raising Induced Changes in Perfusion Index and Pleth Variability Index', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Mountain Emergency Medicine'}, 'officialTitle': 'Prediction of Fluid Responsiveness From Passive Leg Raising Induced Changes in Perfusion Index and Pleth Variability Index', 'orgStudyIdInfo': {'id': '06'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Passive Leg Raising Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'A passive leg raising test is performed in all patients included in the study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '39012', 'city': 'Merano', 'state': 'Bolzano', 'country': 'Italy', 'facility': '"F. Tappeiner" Hospital Merano', 'geoPoint': {'lat': 46.66817, 'lon': 11.15953}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Mountain Emergency Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Anaesthesiology, Merano Hospital, Italy', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Simon Rauch', 'investigatorAffiliation': 'Institute of Mountain Emergency Medicine'}}}}