Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-28 @ 3:26 AM
Study NCT ID:
NCT05507268
Status:
UNKNOWN
Last Update Posted:
2022-08-18
First Post:
2022-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Nomogram for Postoperative Acute Kidney Injury in Older Patients Undergoing Noncardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-17', 'studyFirstSubmitDate': '2022-08-17', 'studyFirstSubmitQcDate': '2022-08-17', 'lastUpdatePostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'acute kidney injury', 'timeFrame': '7 days after surgery', 'description': 'an absolute increase in serum creatinine of 0.3 mg/dl within 48 hours or a 1.5-fold increase from preoperative baseline within 7 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prediction model', 'nomogram', 'older', 'noncardiac surgery'], 'conditions': ['Postoperative Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Postoperative acute kidney injury is associated increased risk of morbidity and mortality. Older patients are at high risk of developing postoperative acute kidney injury. However, the incidence and associations of postoperative acute kidney injury in older patients are not well understood. This study aims to develop and validate a predictive nomogram for postoperative acute kidney injury in older patients undergoing noncardiac surgery.', 'detailedDescription': 'Postoperative acute kidney injury (AKI) affects approximately 2% to 40% of patients undergoing cardiac and major noncardiac surgeries.\n\nOlder patients are more susceptible to renal impairment than younger patients. However, the incidence and associations of AKI in older patients are rarely understood.\n\nGenerally, in-depth knowledge of risk factors and thus able to identify patients at high risk to develop postoperative AKI is essential to optimize perioperative prevention and protection strategies.\n\nIn this retrospective study, the investigators intend to develop and validate a predictive model for postoperative using the identified risk factors.\n\nThe primary outcome is postoperative AKI, which according to the Kidney Disease: Improving Global Outcomes (KDIGO) criterion, is defined as an absolute increase in serum creatinine of 0.3 mg/dL within 48 hours or a 1.5-fold increase from preoperative baseline within 7 days after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Older patients (aged ≥ 65 years) undergoing noncardiac surgery from 2012-2019', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 65 years and older\n\nExclusion Criteria:\n\n* Emergency operation\n* Cardiac surgery\n* Incomplete data\n* Incomplete data\n* Local anesthesia\n* Preoperative renal failure or requirement for dialysis'}, 'identificationModule': {'nctId': 'NCT05507268', 'briefTitle': 'Predictive Nomogram for Postoperative Acute Kidney Injury in Older Patients Undergoing Noncardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Predictive Nomogram for Postoperative Acute Kidney Injury in Older Patients Undergoing Noncardiac Surgery', 'orgStudyIdInfo': {'id': 'PLAGH-AOC-004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'older patients undergoing noncardiac surgery', 'description': 'older patients (aged ≥65 years) scheduled for noncardiac surgery', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['older patients undergoing noncardiac surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weidong Mi, PhD', 'role': 'CONTACT', 'email': 'wwdd1962@163.com', 'phone': '8613381082966'}, {'name': 'Yao Yu, PhD', 'role': 'CONTACT', 'email': '18501088975@163.com', 'phone': '8618501088975'}], 'facility': 'the First Medical Center of Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Weidong Mi, PhD', 'role': 'CONTACT', 'email': 'wwdd1962@163.com', 'phone': '8613381082966'}, {'name': 'Yao Yu, PhD', 'role': 'CONTACT', 'email': '18501088975@163.com', 'phone': '8618501088975'}], 'overallOfficials': [{'name': 'Weidong Mi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Medical Center of Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director (Cheif expert of National key research and development program of China 2018YFC2001900)', 'investigatorFullName': 'Weidong Mi', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}