Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-30 @ 9:04 PM
Study NCT ID:
NCT02041403
Status:
COMPLETED
Last Update Posted:
2014-01-23
First Post:
2014-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RENAL RESISTIVE INDEX POST-OPERATIVE COMPLICATIONS IN MAJOR SURGERY?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-21', 'studyFirstSubmitDate': '2014-01-18', 'studyFirstSubmitQcDate': '2014-01-18', 'lastUpdatePostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications', 'timeFrame': '7 post-operative days', 'description': 'Recording any postoperative complication occurred within the first postoperative week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Major High Risk Operations', 'Renal Resistive Index', 'Outcome']}, 'descriptionModule': {'briefSummary': 'An observational trial aiming to verify whether does any relationship exist between renal resistive index and postoperative outcome in major high risk surgery', 'detailedDescription': 'Renal resistive index was measured just after major high risk operations and then patients were observed searching for any surgical and medical-related complications during the first post-operative week'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients submitted to major high risk surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* major surgical operations\n\nExclusion Criteria:\n\n* age \\< 18 years'}, 'identificationModule': {'nctId': 'NCT02041403', 'briefTitle': 'RENAL RESISTIVE INDEX POST-OPERATIVE COMPLICATIONS IN MAJOR SURGERY?', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'MAY RENAL RESISTIVE INDEX BE AN EARLY PREDICTIVE TOOL OF POST-OPERATIVE COMPLICATIONS IN MAJOR SURGERY?', 'orgStudyIdInfo': {'id': 'CE ICH-158/12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Renal resistive Index'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20100', 'city': 'Milan', 'state': 'Milano', 'country': 'Italy', 'facility': "Sant'Ambrogio Clinical Institute - Cardiac Anesthesia Unit", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'country': 'Italy', 'facility': 'Humanitas Research Hospital - Dept. Anesthesia and Intensive Care Unit', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'overallOfficials': [{'name': 'Enrico Giustiniano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Humanitas Research Hospital -Dept. Anesthesia and Intensive Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}