Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-02 @ 1:39 PM
Study NCT ID:
NCT05752058
Status:
UNKNOWN
Last Update Posted:
2023-05-16
First Post:
2023-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors for Early Acute Lung Injury After Liver Transplantation in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood sample immediately after induction of anesthesia (T1), 10 min at anhepatic stage (T2), 30 min at new hepatic stage (T3) and immediately after abdominal closure (T4)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-14', 'studyFirstSubmitDate': '2023-02-12', 'studyFirstSubmitQcDate': '2023-02-21', 'lastUpdatePostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the score of acute lung injury', 'timeFrame': '1 week after liver transplantation', 'description': 'Murray score was scored from four aspects: chest X-ray, hypoxemia score, positive end-expiratory pressure and lung compliance. The total score was the sum of the scores of all parameters the sum of the number of parameters adopted. The higher the score, the more serious the injury was.'}], 'secondaryOutcomes': [{'measure': 'the expression level of serum microRNA-122,microRNA-21,S100A9,S100A8, TNF-α ,IL-1β and FSTL-1', 'timeFrame': 'immediately after induction of anesthesia (T1), 10 min at anhepatic stage (T2), 30 min at new hepatic stage (T3) and immediately after abdominal closure (T4)', 'description': 'Real-time fluorescence quantitative polymerase chain reaction (RT-qPCR) was used to detect the expression of microRNA-122,microRNA-21,S100A9,S100A8,TNF-α ,IL-1β and FSTL-1 in serum.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute lung injury', 'liver transplantation', 'microRNAs', 'follistatins-like protein 1', 'S100A9 protein'], 'conditions': ['Acute Lung Injury', 'Liver Transplantation', 'Risk Factors']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to identify the risk factors for early acute lung injury (ALI) after liver transplantation in children .The main questions it aims to answer are what the risk factors are for early ALI in children and to evaluate the predictive value for the development of ALI.Participants will be divided into non-ALI group and ALI group according to whether they had ALI in a week after liver transplantation.Researchers will compare the difference between the two groups and use multivariate logistic regression analysis to screen the risk factors of ALI, and receiver operating characteristic(ROC) curve was used to evaluate the predictive efficacy of risk factors.', 'detailedDescription': 'The goal of this observational study is to identify the risk factors for early acute lung injury (ALI) after liver transplantation in children and evaluate the predictive value for the development of ALI.Perioperative data of patients were obtained through electronic case information management system, anesthesia surgery clinical information system and clinical research database. Basic clinical data of children were recorded, including age, gender, alanine aminotransferase (ALT), aspartate aminotransferase (AST), International Normalized ratio (INR), childhood end-stage liver disease score (PELD) and other indicators.The expression levels of serum microRNA-122, microRNA-21, S100A9,S100A8 ,follistim like protein 1(FSTL1), tumor necrosis factor-α (TNF-α) and interleukin-1β(IL-1β) were recorded immediately after induction of anesthesia (T1), 10 min at anhepatic stage (T2), 30 min at new hepatic stage (T3) and immediately after abdominal closure (T4). Intraoperative fluid intake and outflow, ALT, AST, and serum bilirubin peaks in the first week after surgery were recorded.Murray score was used to determine whether ALI occurred one week after surgery, and the children were divided into non-ALI group and ALI group. Multivariate logistic regression analysis was used to screen the risk factors of ALI, and ROC curve was used to evaluate the predictive efficacy of risk factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '3 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children who needed elective parental liver transplantation due to biliary atresia from January 2020 to December 2022', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient was diagnosed with biliary atresia\n* American society of anesthesiologists physical status Ⅱ-Ⅲ\n\nExclusion Criteria:\n\n* Secondary liver transplantation or other important organ injury before surgery\n* Present with congenital airway or respiratory malformation\n* Acute respiratory infection or respiratory insufficiency was present within 1 month before surgery\n* Incomplete data'}, 'identificationModule': {'nctId': 'NCT05752058', 'briefTitle': 'Risk Factors for Early Acute Lung Injury After Liver Transplantation in Children', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin First Central Hospital'}, 'officialTitle': 'Risk Factors for Early Acute Lung Injury After Liver Transplantation in Children and the Prediction Vaulen', 'orgStudyIdInfo': {'id': '2022N105KY'}}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin First Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Yingli Cao', 'investigatorAffiliation': 'Tianjin First Central Hospital'}}}}