Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT05783518
Status:
UNKNOWN
Last Update Posted:
2023-03-24
First Post:
2023-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Desflurane on Pediatric Acute Respiratory Distress Syndrome After Living Donor Liver Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001656', 'term': 'Biliary Atresia'}], 'ancestors': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077335', 'term': 'Desflurane'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D005019', 'term': 'Ethyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 165}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2023-03-12', 'studyFirstSubmitQcDate': '2023-03-23', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of PARDS', 'timeFrame': '7 days after LDLT', 'description': 'the definition of PARDS recommended by the 2015 Pediatric Acute Lung Injury Consensus Conference'}], 'secondaryOutcomes': [{'measure': 'High mobility group box 1', 'timeFrame': 'immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）', 'description': 'Peripheral blood is collected'}, {'measure': 'Interleukin-6', 'timeFrame': 'immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）', 'description': 'Peripheral blood is collected'}, {'measure': 'Tumor necrosis factor-alpha', 'timeFrame': 'immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）', 'description': 'Peripheral blood is collected'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric Acute Respiratory Distress Syndrome', 'Living Donor Liver Transplant', 'Desflurane', 'Biliary atresia'], 'conditions': ['Pediatric Acute Respiratory Distress Syndrome', 'Desflurane', 'Biliary Atresia']}, 'referencesModule': {'references': [{'pmid': '34781099', 'type': 'BACKGROUND', 'citation': 'Lendahl U, Lui VCH, Chung PHY, Tam PKH. Biliary Atresia - emerging diagnostic and therapy opportunities. EBioMedicine. 2021 Dec;74:103689. doi: 10.1016/j.ebiom.2021.103689. Epub 2021 Nov 12.'}, {'pmid': '32861448', 'type': 'BACKGROUND', 'citation': 'Chung PHY, Zheng S, Tam PKH. Biliary atresia: East versus west. Semin Pediatr Surg. 2020 Aug;29(4):150950. doi: 10.1016/j.sempedsurg.2020.150950. Epub 2020 Jul 23.'}, {'pmid': '18261594', 'type': 'BACKGROUND', 'citation': 'Karakayali H, Sevmis S, Ozcelik U, Ozcay F, Moray G, Torgay A, Arslan G, Haberal M. Liver transplantation for biliary atresia. Transplant Proc. 2008 Jan-Feb;40(1):231-3. doi: 10.1016/j.transproceed.2007.11.015.'}, {'pmid': '17621602', 'type': 'BACKGROUND', 'citation': 'Schilling T, Kozian A, Kretzschmar M, Huth C, Welte T, Buhling F, Hedenstierna G, Hachenberg T. Effects of propofol and desflurane anaesthesia on the alveolar inflammatory response to one-lung ventilation. Br J Anaesth. 2007 Sep;99(3):368-75. doi: 10.1093/bja/aem184. Epub 2007 Jul 9.'}]}, 'descriptionModule': {'briefSummary': 'Biliary atresia is a serious congenital anomaly characterized by persistent and progressive cholestatic jaundice. The incidence of biliary atresia is more common in East Asia, especially China, with an incidence of 2 per 10,000 live births. Liver transplantation is the only effective way to treat end-stage liver disease. However, distant organ damage, affecting the heart, brain, kidneys, lungs, and intestines, is still an important factor affecting the long-term survival of children after surgery. Desflurane is a volatile anesthetic commonly used in surgery. In order to observe the effect of desflurane on the incidence of early postoperative pediatric acute respiratory distress syndrome (PARDS) with biliary atresia who underwent living donor liver transplantation, and explore the related mechanism, a total of 165 infant patients underwent living liver transplantation due to biliary atresia from March 2023 to October 2023 are included in our single-center prospective study. They are randomly divided into propofol group (n=55), propofol and desflurane group (n=55) and desflurane group (n=55) according to the difference of intraoperative anesthesia maintenance. Gender, age, height, weight, PELD scores and other preoperative basic data are recorded. Operation time, anhepatic time and intraoperative blood loss volume are recorded. The basic information of liver donors are also recorded. Postoperative mechanical ventilation time, ICU stay time, tacrolimus concentration, total length of hospital stay and mortality during hospitalization are recorded. According to the the definition of PARDS recommended by the 2015 Pediatric Acute Lung Injury Consensus Conference is used as the diagnostic and grading criteria for postoperative PARDS, and the incidence and grading of PARDS within the first seven days after surgery are evaluated in the three groups. Peripheral blood is collected immediately after anesthesia induction, 30min after reperfusion and at the end of surgery to detect serum levels of HMGB1, IL-6 and TNF-α by enzyme linked immunosorbent assay (ELISA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The diagnosis was biliary atresia\n* Living donors were either the father or the mother\n* 3months ≤age ≤ 36 months\n\nExclusion Criteria:\n\n* The preoperative diagnosis was not biliary atresia\n* The donor was not a parent\n* Age \\<3months or\\>36 months\n* The patient had perinatal disease or congenital cardiopulmonary deformity\n* The patient had acute respiratory infection before surgery\n* The patient had hepatopulmonary syndrome\n* Retransplantation'}, 'identificationModule': {'nctId': 'NCT05783518', 'acronym': 'EDPARDSLDLTR', 'briefTitle': 'Effect of Desflurane on Pediatric Acute Respiratory Distress Syndrome After Living Donor Liver Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin First Central Hospital'}, 'officialTitle': 'Effect of Desflurane on Pediatric Acute Respiratory Distress Syndrome After Living Donor Liver Transplant Recipients', 'orgStudyIdInfo': {'id': 'Desflurane on PARDS after LDLT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'propofol group', 'interventionNames': ['Drug: propofol']}, {'type': 'EXPERIMENTAL', 'label': 'propofol and desflurane group', 'interventionNames': ['Drug: desflurane', 'Drug: propofol']}, {'type': 'EXPERIMENTAL', 'label': 'desflurane group', 'interventionNames': ['Drug: desflurane']}], 'interventions': [{'name': 'desflurane', 'type': 'DRUG', 'description': 'Intraoperative anesthesia maintenance', 'armGroupLabels': ['desflurane group', 'propofol and desflurane group']}, {'name': 'propofol', 'type': 'DRUG', 'description': 'Intraoperative anesthesia maintenance', 'armGroupLabels': ['propofol and desflurane group', 'propofol group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300192', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'contacts': [{'name': 'Yimei Cao', 'role': 'CONTACT', 'email': 'caoyimei@yeah.net', 'phone': '8613426335223'}], 'facility': 'TianjinFCH', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '300192', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'TianjinFCH', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin First Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The First Central Clinical College of Tianjin Medical University', 'investigatorFullName': 'Yimei, Cao', 'investigatorAffiliation': 'Tianjin First Central Hospital'}}}}