Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT04967105
Status:
COMPLETED
Last Update Posted:
2022-03-11
First Post:
2021-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019265', 'term': 'Spectroscopy, Near-Infrared'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2021-07-12', 'studyFirstSubmitQcDate': '2021-07-14', 'lastUpdatePostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative acute kidney injury', 'timeFrame': 'Postoperative 7 days', 'description': 'Postoperative acute kidney injury is defined according to the KDIGO criterion'}], 'secondaryOutcomes': [{'measure': 'Death before and 30 days after discharge', 'timeFrame': '30 days after discharge', 'description': 'Collection of clinical data in the medical record and follow-up update through telephone'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Postoperative 30 days', 'description': 'Collection of clinical data in the medical record'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver resection', 'elderly', 'renal oxygen saturation', 'near-infrared spectroscopy'], 'conditions': ['Postoperative Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the changes in renal regional oxygen saturation (rSO2) monitored by near-infrared spectroscopy (NIRS) and its relationship with the occurrence of postoperative AKI.', 'detailedDescription': 'Postoperative acute kidney injury (AKI) is a severe complication after liver resection and contributes to increased morbidity and mortality.\n\nAdvanced age reduces renal autoregulatory capacity due to physiological and functional changes, thus render the elderly to suffer postoperative AKI and probably the consequent chronic kidney disease. Thus, it is essential to identify those patients at high risk to develop postoperative AKI to optimize perioperative prevention and protection strategies.\n\nDespite the multiple risk factors and potential mechanisms that have been identified, the diagnosis of postoperative AKI depending on serum creatinine changes have been delayed for early identification of postoperative AKI. It is of great interest to develop target strategies for close motoring of renal function.\n\nThis study is a prospective cohort study to investigate the associations between intraoperative renal desaturation measured by NIRS and postoperative AKI. The investigators intend to access the optimal threshold values of renal rSO2 for predicting postoperative AKI. Desaturation of renal rSO2 will be defined by the severity and duration of NIRS values during the surgical process. The principal clinical outcome of the study is postoperative AKI, 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 seven days after surgery, according to the Kidney Disease: Improving Global Outcomes (KDIGO) criterion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients older than 60 years who intend to receive elective hepatectomy surgeries', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elderly patients (defined as 60 years of age or older) scheduled for elective liver resection\n\nExclusion Criteria:\n\n* Emergency surgery\n* Liver transplantation\n* Preoperative hemodialysis\n* BMI \\> 30\n* Renal depth (distance from the capsule of the kidney to the skin surface) \\> 4 cm\n* Unable or failed to sign the informed consent'}, 'identificationModule': {'nctId': 'NCT04967105', 'briefTitle': 'Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury in Elderly Patients Undergoing Liver Resection: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'PLAGH-AOC-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'elderly patients following liver resection', 'description': 'elderly patients (aged ≥60 years) scheduled for any type of liver resection due to benign or malignant hepatobiliary diseases', 'interventionNames': ['Device: Near-infrared spectroscopy']}], 'interventions': [{'name': 'Near-infrared spectroscopy', 'type': 'DEVICE', 'description': 'Before the induction of anesthesia, NIRS sensors were placed on both sides of the flank area that overlies the kidney to monitor renal SO2, whose alteration trends over time during operation will be recorded and evaluated in later analysis.', 'armGroupLabels': ['elderly patients following liver resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Weidong Mi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Tsinghua Changgeng 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'}}}}