Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-27 @ 10:48 AM
Study NCT ID:
NCT03882658
Status:
COMPLETED
Last Update Posted:
2019-05-07
First Post:
2019-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Serum Albumin and Duration of Intraoperative Hypotension on Postoperative Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37610}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-04', 'studyFirstSubmitDate': '2019-03-18', 'studyFirstSubmitQcDate': '2019-03-18', 'lastUpdatePostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence and odds ratio of postoperative acute kidney injury', 'timeFrame': '30 days postoperatively in hospital', 'description': 'incidence and odds ratio of postoperative acute kidney injury'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Acute kidney injury is one of major adverse postoperative complications. research about postoperative acute kidney injury conclude that low preoperative albumin and intraoperative hypotension is associated to postoperative acute kidney injury. However, due to ethic issue and nonlinear realtionship between these factors and postoperative acute kidney injury, the exact threshold of these two risk factors were not be able to identified. The research tried to locate the exact threshold with implementation of penalized splines by generalized additive model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult non-cardiac, non-obsteric, non- kidney elective surgery patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nadult non-cardiac, non-obsteric, non- kidney elective surgery patients\n\nExclusion Criteria:\n\npatients aged \\<18 y emergency surgeries without arterial blood pressure cardiac surgeries obstetric surgeries kidney surgeries under local infiltration or MAC first SBP \\<100 mmHg'}, 'identificationModule': {'nctId': 'NCT03882658', 'briefTitle': 'Preoperative Serum Albumin and Duration of Intraoperative Hypotension on Postoperative Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'Preoperative Serum Albumin and Duration of Intraoperative Hypotension on Postoperative Acute Kidney Injury: a Retrospective Cohort Analysis', 'orgStudyIdInfo': {'id': 'ALBHYTAKI'}}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'First hospital Peking University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yan Zhou, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University First Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yan Zhou, MD', 'investigatorAffiliation': 'Peking University First Hospital'}}}}