Viewing Study NCT05752058


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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: Tianjin First Central Hospital
Organization:

Study Overview

Official Title: Risk Factors for Early Acute Lung Injury After Liver Transplantation in Children and the Prediction Vaulen
Status: UNKNOWN
Status Verified Date: 2023-05
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: