Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 5:44 PM
Study NCT ID:
NCT07135206
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk of Acute Kidney Injury in Pulmonary Endarterectomy
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Venous blood (3mL per time point) and mid-stream urine (5mL per time point) will be collected. Serum and urine supernatant will be stored at -80℃ after centrifugation. Samples are used for detecting biomarkers such as NGAL and KIM-1, without DNA extraction.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 284}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Acute Kidney Injury (AKI) after Pulmonary Endarterectomy (PEA)', 'timeFrame': 'Within 7 days after PEA surgery', 'description': 'Acute kidney injury is defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria, which includes three stages based on serum creatinine (Scr) elevation and urine output reduction. Scr\\>1.5 times baseline or ≥0.3 mg/dl increase, or urine output \\<0.5 ml/kg/h for 6-12h'}], 'secondaryOutcomes': [{'measure': 'Recovery of Renal Function', 'timeFrame': '1 months after surgery', 'description': 'Proportion of patients whose Scr returns to ≤120% of baseline level before discharge.'}, {'measure': 'Use of Renal Replacement Therapy (RRT) survey', 'timeFrame': 'Within 3 months after surgery', 'description': 'Incidence of postoperative dialysis or continuous renal replacement therapy (CRRT).'}, {'measure': 'duration of postoperative dialysis or continuous renal replacement therapy (CRRT).', 'timeFrame': 'Within 3 months after surgery', 'description': 'Use of Renal Replacement Therapy (RRT)'}, {'measure': 'Changes in Estimated Glomerular Filtration Rate (eGFR) from Baseline to 3 Months Postoperatively', 'timeFrame': '3 months after surgery', 'description': 'This outcome assesses the numerical change in estimated glomerular filtration rate (eGFR) of patients from preoperative baseline to 3 months after surgery. eGFR will be calculated using a clinically validated formula (e.g., CKD-EPI formula), with the unit of mL/(min·1.73 m²).'}, {'measure': 'Progression to Chronic Kidney Disease (CKD) at 3 Months Postoperatively', 'timeFrame': '3 months after surgery', 'description': 'This outcome evaluates whether patients progress to chronic kidney disease (CKD) 3 months after surgery. CKD is defined as a persistent estimated glomerular filtration rate (eGFR) \\< 60 mL/(min·1.73 m²) for ≥ 3 months (meeting the standard CKD diagnostic criteria). The assessment result is a categorical variable (Yes/No) (i.e., whether the patient progresses to CKD).'}, {'measure': 'Dynamic Changes of Neutrophil Gelatinase-Associated Lipocalin (NGAL) and Kidney Injury Molecule-1 (KIM-1) and Their Correlation with AKI Occurrence and Severity', 'timeFrame': 'From preoperative to 72 hours postoperatively', 'description': 'This outcome focuses on detecting the levels of two novel biomarkers-neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1)-in serum and urine samples collected from patients at multiple predefined time points. The sampling time points include the preoperative period, 2 hours and 6 hours during cardiopulmonary bypass (CPB), and 0 hours, 24 hours, and 72 hours postoperatively. Additionally, this outcome will analyze the correlation between the dynamic changes in NGAL and KIM-1 levels and two key indicators of AKI: the occurrence of AKI (as defined by KDIGO criteria) and the severity of AKI (KDIGO Stage I, II, or III). Biospecimens (3ml venous blood and 5ml midstream urine per time point) will be processed by centrifugation, with serum and urine supernatant stored at -80°C before biomarker detection, and no DNA extraction will be performed on the samples'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the perioperative risk factors for acute kidney injury (AKI) in patients undergoing pulmonary endarterectomy (PEA) with deep hypothermic circulatory arrest (DHCA). By analyzing retrospective data (2016-2025) from approximately 240 PEA patients and prospectively enrolling 44 patients (2025-2027), we will identify clinical risk factors, establish and validate a comprehensive prediction model, and explore the dynamic characteristics and predictive value of novel biomarkers (e.g., NGAL, KIM-1). The goal is to improve early warning and management of PEA-related AKI, thereby enhancing patient outcomes.', 'detailedDescription': 'Background: PEA is the radical treatment for chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary artery sarcoma, requiring DHCA to ensure a bloodless surgical field. However, AKI occurs in 10-49% of PEA patients, significantly higher than neurological injury, leading to prolonged hospitalization and increased mortality. The risk factors and predictive biomarkers for PEA-related AKI remain unclear, highlighting the need for this research.\n\nStudy Design: A single-center, dual-cohort study including:\n\nRetrospective Cohort: Patients who underwent PEA at China-Japan Friendship Hospital from 2016 to 2025. Data on baseline characteristics, intraoperative parameters (CPB/DHCA duration, perfusion pressure), postoperative renal function (based on KDIGO criteria), and outcomes (e.g., renal replacement therapy) will be collected to identify risk factors.\n\nProspective Cohort: Patients scheduled for PEA from 2025 to 2027. Clinical data and biological samples (blood/urine) will be collected at multiple time points (preoperatively, 2h/6h during CPB, 0h/24h/72h postoperatively) to measure biomarkers (NGAL, KIM-1, Scr, BUN). This cohort will validate the prediction model and assess biomarker performance.\n\nObjectives:\n\nIdentify independent risk factors for PEA-related AKI. Develop and validate a perioperative prediction model for AKI. Clarify the dynamic changes and diagnostic/predictive value of novel biomarkers.\n\nOutcome Measures:\n\nPrimary: AKI occurrence (KDIGO criteria). Secondary: AKI recovery rate, renal replacement therapy usage, hospital stay, 3-month mortality, and changes in renal/cardiopulmonary function.\n\nSignificance: This study will fill gaps in perioperative renal protection for PEA, provide an evidence-based risk assessment tool, and lay the foundation for optimized clinical management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary artery sarcoma who undergo pulmonary endarterectomy (PEA) with deep hypothermic circulatory arrest (DHCA) at China-Japan Friendship Hospital. The study aims to evaluate perioperative risk factors for PEA-related acute kidney injury (AKI) and the value of novel biomarkers 。', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary artery sarcoma, and scheduled for or having undergone pulmonary endarterectomy (PEA) .\n\nAged 18 to 85 years . Underwent PEA using cardiopulmonary bypass (CPB) combined with deep hypothermic circulatory arrest (DHCA) technology .\n\nComplete clinical data (including preoperative baseline data, intraoperative CPB/DHCA parameters, and postoperative respiratory, circulatory, and renal function data) .\n\nAvailable renal function indicators at 3 months after surgery .\n\nExclusion Criteria:\n\nReceiving preoperative maintenance renal replacement therapy . Complicated with severe liver failure, end-stage malignant tumors, or other diseases that affect short-term prognosis .\n\nMissing key data (e.g., CPB/DHCA duration, postoperative 72-hour serum creatinine \\[Scr\\]) that cannot be supplemented .'}, 'identificationModule': {'nctId': 'NCT07135206', 'acronym': 'PEAAKI', 'briefTitle': 'Risk of Acute Kidney Injury in Pulmonary Endarterectomy', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Perioperative Risk Assessment of Acute Kidney Injury Related to Pulmonary Endarterectomy Under Deep Hypothermic Circulatory Arrest', 'orgStudyIdInfo': {'id': 'ZRYH-PEA-AKI-2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PEA Patients with AKI Risk Assessment Cohort', 'description': 'This cohort integrates retrospective and prospective data from patients undergoing pulmonary endarterectomy (PEA) with deep hypothermic circulatory arrest (DHCA) at China-Japan Friendship Hospital. It includes: 1) Retrospective cases (2016-2025, \\~240 cases) to explore perioperative risk factors for PEA-related acute kidney injury (AKI); 2) Prospective cases (2025-2027, 44 cases) to validate prediction models and analyze dynamic biomarkers (e.g., NGAL, KIM-1). The cohort aims to comprehensively assess AKI risk through combined analysis of historical and real-time data.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Li Fang Wang Dr., MD', 'role': 'CONTACT', 'email': 'lilythewolf@sina.com', 'phone': '+8684205883'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lifang Wang, M.D.', 'role': 'CONTACT', 'email': 'lilythewolf@sina.com', 'phone': '8601084205882'}, {'name': 'Yinghui Fang, M.D.', 'role': 'CONTACT', 'phone': '86-10-18810488373'}], 'overallOfficials': [{'name': 'Lifang Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China-Japan Friendship Hospital, Department of Anesthesiology'}]}, 'ipdSharingStatementModule': {'url': 'https://www.medicalresearch.org.cn', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Individual participant data (IPD) and supporting information will be made available within 1 month after the publication of study results, with access maintained for 5 years after study completion.', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) will be shared with qualified researchers upon reasonable request, following publication of the study results. Shared data will include de-identified clinical information (baseline characteristics, intraoperative parameters, postoperative outcomes) and biomarker data, excluding direct identifiers to protect participant privacy. Data access will require approval from the institutional review board of China-Japan Friendship Hospital and a signed data use agreement specifying the purpose of use and confidentiality obligations. The data will be shared via a secure research data repository for up to 5 years after study completion', 'accessCriteria': "Eligible researchers must submit a research application specifying the purpose of data use and research plan, which will be reviewed and approved by the Institutional Review Board of China-Japan Friendship Hospital.A data use agreement must be signed, committing to use the data solely for scientific research, protect participants' privacy, refrain from unauthorized data transfer, and cite this study in published outcomes.De-identified data will be accessible through the hospital's designated secure data repository."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Li Fang Wang', 'investigatorFullName': 'Li Fang Wang', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}