Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-28 @ 7:59 AM
Study NCT ID:
NCT04518332
Status:
UNKNOWN
Last Update Posted:
2021-10-04
First Post:
2020-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Cerebral and Renal Tissue Oxygen Saturation and Pediatric Living Donor Liver Transplantation Prognosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 123}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-26', 'studyFirstSubmitDate': '2020-08-16', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Developmental delay', 'timeFrame': '10days', 'description': 'Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.'}, {'measure': 'Developmental delay', 'timeFrame': '1 month', 'description': 'Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.'}, {'measure': 'Developmental delay', 'timeFrame': '3 months', 'description': 'Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.'}, {'measure': 'Developmental delay', 'timeFrame': '6 months', 'description': 'Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.'}, {'measure': 'Developmental delay', 'timeFrame': '1 year', 'description': 'Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.'}, {'measure': 'Developmental delay', 'timeFrame': '2 years', 'description': 'Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.'}, {'measure': 'Developmental delay', 'timeFrame': '3 years', 'description': 'Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.'}, {'measure': 'Socioemotional Delay', 'timeFrame': '10days', 'description': 'Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.'}, {'measure': 'Socioemotional Delay', 'timeFrame': '1 month', 'description': 'Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.'}, {'measure': 'Socioemotional Delay', 'timeFrame': '3 months', 'description': 'Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.'}, {'measure': 'Socioemotional Delay', 'timeFrame': '6 months', 'description': 'Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.'}, {'measure': 'Socioemotional Delay', 'timeFrame': '1 year', 'description': 'Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.'}, {'measure': 'Socioemotional Delay', 'timeFrame': '2 years', 'description': 'Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.'}, {'measure': 'Socioemotional Delay', 'timeFrame': '3 years', 'description': 'Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '30 days', 'description': 'Postoperative complications including Cardiovascular system, respiratory system, digestive system, urinary system, blood system will be screened.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Liver Transplantation', 'Developmental Delay', 'Postoperative Complications', 'Socioemotional Delay']}, 'descriptionModule': {'briefSummary': 'This rSO2 study is a prospective clinical study. The purpose of the rSO2 study is to investigate whether there is a correlation between the intraoperative cerebral and renal tissue oxygen saturation and the incidence of developmental and socioemotional delay after living donor liver transplantation for children. This study will also investigate whether intraoperative cerebral and renal tissue oxygen saturation are related to postoperative complications.', 'detailedDescription': 'There is high incidence of developmental and socioemotional delay and postoperative complications in pediatric living donor liver transplantation patients. In this prospective observational clinical study, the investigators aim to investigate the correlation between the intraoperative cerebral and renal tissue oxygen saturation and the incidence of developmental and socioemotional delay and postoperative complications. This study will enroll patients aged from 6 to 36 months old who are scheduled for elective standard living-donor liver transplantation and have signed informed consent before the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will enroll patients aged from 6 to 36 months old who are scheduled for elective standard living-donor liver transplantation and have signed informed consent before the surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pediatric patients (6 months\\< the Moon's age \\<36 months) who will receive standard living-donor liver transplantation (LDLT) in Renji Hospital.\n\nExclusion Criteria:\n\n* Forehead skin infection, A history of liver transplantation, Multivisceral transplantation, Refused to participate the study"}, 'identificationModule': {'nctId': 'NCT04518332', 'acronym': 'rSO2-LDLT', 'briefTitle': 'Intraoperative Cerebral and Renal Tissue Oxygen Saturation and Pediatric Living Donor Liver Transplantation Prognosis.', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Association of Intraoperative Cerebral and Renal Tissue Oxygen Saturation With Developmental and Socioemotional Delay and Postoperative Complications After Living Donor Liver Transplantation for Children: an Observational Study.', 'orgStudyIdInfo': {'id': '20200808'}}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Pudong', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dan Huang', 'role': 'CONTACT', 'email': 'huangdan@renji.com', 'phone': '15921108822'}], 'facility': 'Renji Hospital', 'geoPoint': {'lat': 31.23995, 'lon': 121.50094}}], 'centralContacts': [{'name': 'Dan Huang, M.S.', 'role': 'CONTACT', 'email': 'huangdan363@163.com', 'phone': '+86 15921108822'}], 'overallOfficials': [{'name': 'Weifen Yu, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}