Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2026-02-19 @ 5:59 AM
Study NCT ID:
NCT03323203
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2017-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Tissue Oxygen Saturation With Postoperative Acute Kidney Injury in Double Valves Replacement Surgery
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-28', 'studyFirstSubmitDate': '2017-10-24', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative acute kidney injury (AKI)', 'timeFrame': 'Seven days postoperatively', 'description': 'AKI is defined as any of the following (Not Graded):\n\n* K Increase in serum creatinine (SCr) by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or\n* K Increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or\n* K Urine volume o0.5 ml/kg/h for 6 hours.AKI is defined as any of the following (Not Graded):\n* K Increase in SCr by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or\n* K Increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or\n* K Urine volume o0.5 ml/kg/h for 6 hours.\n\nAKI is defined as any of the following (Not graded):Increase in SCr by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or urine volume less than 0.5 ml/kg/h for 6 hours.'}], 'secondaryOutcomes': [{'measure': 'Length of mechanical ventilation', 'timeFrame': 'Postoperative day 0-day 7', 'description': 'Time between intubation and extubation'}, {'measure': 'Length of ICU stay', 'timeFrame': 'Postoperative day 0-day 7', 'description': 'Days between end of operation and departure of ICU'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Postoperative day 0-day 30', 'description': 'Days between end of operation and hospital discharge'}, {'measure': 'Adverse events in 30 days', 'timeFrame': 'Postoperative day 0-day 30', 'description': 'Clinical events since hospital discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '37726660', 'type': 'DERIVED', 'citation': 'Zhang H, Zhang T, Hou L, Zhao J, Fan Q, Wang L, Lu Z, Dong H, Lei C. Association of intraoperative cerebral and somatic tissue oxygen saturation with postoperative acute kidney injury in adult patients undergoing multiple valve surgery. BMC Anesthesiol. 2023 Sep 19;23(1):319. doi: 10.1186/s12871-023-02279-7.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the relationship of tissue oxygenation of different organs and tissue beds (e.g., a tissue bed on the arm vs. leg vs. flank tissue bed(s) and renal tissue bed, and thus can be used as a surrogate of renal tissue oxygenation monitoring.', 'detailedDescription': 'In this study, we will monitor tissue oxygenation of four different tissue beds including cerebral tissue (SctO2) on the forehead, and 3 somatic tissue beds monitored on the forearm (SarmO2), upper leg (SlegO2), and the renal region (SrrO2). The primary end point is AKI and the secondary end points are postoperative major non-renal complications (e.g. stroke, delirium, myocardial infraction, heart failure, new or worsening arrhythmia, mechanical ventilation \\> 24 hours, deep wound infection, etc.) and mortality. The associations between tissue oxygenation of different tissue beds, i.e. SctO2, SarmO2, SlegO2, and SrrO2, and AKI and non-renal outcomes will be compared to explore the tissue bed(s) whose oxygen saturation has a stronger association with the outcomes of interest. The strength of this study is to use the patient as self-control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are going to have double valves replacement surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent obtained\n* Age ≥18 years of age\n* Double valves replacement surgery with cardiopulmonary bypass (CPB)\n\nExclusion Criteria:\n\n* The Trauma, deformity or abnormality sites which the sensor will be put may affect the monitoring of the data\n* Preoperative renal dysfunction needs renal replacement therapy\n* Emergency surgery\n* Preoperative intubated patient\n* Unable to cooperate with the study, i.e., mental illness, et al\n* Patients with hemoglobin and anemia\n* Participate in other trials in the prior 3 months\n* Patient refuses to participate in the study\n* Patient is unfit for the study decided by reach stuff'}, 'identificationModule': {'nctId': 'NCT03323203', 'briefTitle': 'Association of Tissue Oxygen Saturation With Postoperative Acute Kidney Injury in Double Valves Replacement Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Association of Intraoperative Cerebral and Somatic Tissue Oxygen Saturation With Postoperative Acute Kidney Injury in Adult Patients Undergoing Double Valves Replacement Surgery', 'orgStudyIdInfo': {'id': 'KY20172070-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA', 'type': 'DEVICE', 'description': 'Tissue oxygenation was monitored using a tissue oximeter based on near-infrared spectroscopy (FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA). The oximeter had four cables with each cable connected to an adhesive probe.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Hailong Dong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xijing Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.& Ph.D.', 'investigatorFullName': 'chonglei', 'investigatorAffiliation': 'Xijing Hospital'}}}}