Clinical trial NCT05752058: Risk Factors for Early Acute Lung Injury After Liver Transplantation in Children
Official title: Risk Factors for Early Acute Lung Injury After Liver Transplantation in Children and the Prediction Vaulen
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lung Injury
Liver Transplantation
Risk Factors
Keywords: Acute lung injury
liver transplantation
microRNAs
follistatins-like protein 1
S100A9 protein
Lead sponsor: Tianjin First Central Hospital
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who needed elective parental liver transplantation due to biliary atresia from January 2020 to December 2022

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patient was diagnosed with biliary atresia
* American society of anesthesiologists physical status Ⅱ-Ⅲ

Exclusion Criteria:

* Secondary liver transplantation or other important organ injury before surgery
* Present with congenital airway or respiratory malformation
* Acute respiratory infection or respiratory insufficiency was present within 1 month before surgery
* Incomplete data

Primary outcomes:
measure: the score of acute lung injury
timeFrame: 1 week after liver transplantation
Secondary outcomes:
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)
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