Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 11:35 PM
Study NCT ID:
NCT07141693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-26
First Post:
2025-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Renal Oximetry-Guided Anesthesia With Near-Infrared Spectroscopy for Improved Postoperative Outcomes
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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2025-08-09', 'studyFirstSubmitQcDate': '2025-08-25', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Actue kidney injury', 'timeFrame': 'Postoperative Day 1-7', 'description': 'An increase in serum creatinine of ≥26.5 μmol/L from baseline within 48 hours or an increase of ≥50% from baseline within 7 days'}, {'measure': 'Comprehensive Complication Index', 'timeFrame': 'Postoperative Day 1-28', 'description': 'The co-primary outcome is the Comprehensive Complication Index (CCI) score, which includes all complications occurring from randomization to the 28-day follow-up period and calculated using the Clavien-Dindo classification (CDC).'}], 'secondaryOutcomes': [{'measure': 'Total duration and proportion of time during surgery of renal desaturation', 'timeFrame': 'Intraoperative', 'description': 'Total duration and proportion of time during surgery when renal oxygen saturation decreases by \\>10% from baseline'}, {'measure': 'Area under the curve for renal oxygen desaturation', 'timeFrame': 'Intraoperative', 'description': 'Area under the curve for renal oxygen saturation decrease by \\>10% from baseline'}, {'measure': 'Use of vasoactive drugs', 'timeFrame': 'Intraoperative', 'description': 'The type and total dose of vasoactive drugs'}, {'measure': 'Intraoperative blood pressure levels', 'timeFrame': 'Intraoperative', 'description': 'Intraoperative low blood pressure and the lowest level'}, {'measure': 'AKI grading', 'timeFrame': 'Postoperative Day 1-7', 'description': 'According to serum creatinine level to conduct AKI grade'}, {'measure': 'Overall incidence of postoperative complications', 'timeFrame': 'Postoperative Day 1-28', 'description': 'Overall incidence of postoperative complications, including neurological, respiratory, cardiovascular complications, acute kidney injury, and sepsis.'}, {'measure': 'mortality', 'timeFrame': 'Postoperative Day 1-28', 'description': 'In-hospital mortality and 28-day postoperative mortality'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The trial is a prospective, randomized, single-blind, pilot study investigating whether near-infrared spectroscopy (NIRS)-guided optimization of intraoperative renal oxygen saturation (SrtO₂) reduces postoperative acute kidney injury (AKI) in patients undergoing elective hepatectomy. The trial will enroll 80 adults (≥45 years, American society of Aneshesiologists physical status I-III), randomizing them to either standard anesthesia management or NIRS-guided management where a predefined 6-step intervention protocol (volume optimization, vasoactive drugs, inotropes, heart rate management, transfusion, and FiO₂ management) is triggered if SrtO₂ decreases \\>10% from baseline. Primary outcomes are the incidence of AKI within 7 days and the 28-day Comprehensive Complication Index (CCI). The study aims to determine if real-time SrtO₂ monitoring and proactive intervention can prevent this serious complication, based on previous observational data linking renal desaturation to AKI risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 45 years\n* Scheduled for elective hepatectomy\n* Planned for general anesthesia with endotracheal intubation\n* BMI \\< 30 kg/m2\n* Preoperative ultrasound shows renal cortical to skin distance ≤ 4 cm\n* ASA classification I-III\n* Consenting to participate and signing informed consent\n\nExclusion Criteria:\n\n* Liver transplantation surgery\n* Preoperative renal dysfunction or requirement for dialysis treatment;\n* Contraindications to vasoactive drugs such as norepinephrine or dopamine as determined by the clinician;\n* Severe cardiopulmonary insufficiency (severe arrhythmia, heart failure, respiratory failure, chronic obstructive pulmonary disease), or a serious cardiovascular or cerebrovascular event within the last six months before randomization (such as acute heart failure, acute myocardial infarction, stroke, etc.);\n* Patient refusal to participate or current participation in another experimental study;\n* Other factors deemed unsuitable for inclusion by the researcher.'}, 'identificationModule': {'nctId': 'NCT07141693', 'acronym': 'ROGAR', 'briefTitle': 'Renal Oximetry-Guided Anesthesia With Near-Infrared Spectroscopy for Improved Postoperative Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Renal Oximetry-Guided Anesthesia With Near-Infrared Spectroscopy for Improved Postoperative Outcomes in Hepatectomy: A Dual-Center, Prospective, Randomized, Single-Blind Investigator-Initiated Pilot Trial', 'orgStudyIdInfo': {'id': 'ChinesePLA_ROGAR_Pilot'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NIRS-guided anesthesia management group', 'description': 'NIRS-guided management where a predefined 6-step intervention protocol (volume optimization, vasoactive drugs, inotropes, heart rate management, transfusion, and FiO₂ increase)', 'interventionNames': ['Procedure: NIRS-guided management']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard anesthesia management', 'description': 'standard anesthesia management', 'interventionNames': ['Procedure: Standard anesthesia management']}], 'interventions': [{'name': 'NIRS-guided management', 'type': 'PROCEDURE', 'description': 'NIRS-guided management where a predefined 6-step intervention protocol (volume optimization, vasoactive drugs, inotropes, heart rate management, transfusion, and FiO₂ increase)', 'armGroupLabels': ['NIRS-guided anesthesia management group']}, {'name': 'Standard anesthesia management', 'type': 'PROCEDURE', 'description': 'Standard anesthesia management', 'armGroupLabels': ['Standard anesthesia management']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Tsinghua Changgeng Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Hao Li', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}