Risk Factors for Early Acute Lung Injury After Liver Transplantation in Children

Liver Transplantation Clinical Trial

Official title:

Risk Factors for Early Acute Lung Injury After Liver Transplantation in Children and the Prediction Vaulen

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05752058
• Other study ID #: 2022N105KY
• Status: Not yet recruiting
• Start date: August 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Tianjin First Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 2 Years

Eligibility

Inclusion Criteria:

• patient was diagnosed with biliary atresia
• American society of anesthesiologists physical status ?-?

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Liver Transplantation
• Lung Injury
• Risk Factors
• Wounds and Injuries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin First Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the score of acute lung injury	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.	1 week after liver transplantation
Secondary	the expression level of serum microRNA-122,microRNA-21,S100A9,S100A8, TNF-a ,IL-1ß and FSTL-1	Real-time fluorescence quantitative polymerase chain reaction (RT-qPCR) was used to detect the expression of microRNA-122,microRNA-21,S100A9,S100A8,TNF-a ,IL-1ß and FSTL-1 in serum.	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)