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

NCT05752058 | Unknown DMC

• 1 other identifier: 2022N105KY
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Lung Injury; Liver Transplantation; Risk Factors

Keywords

Acute lung injury; liver transplantation; microRNAs; follistatins-like protein 1; S100A9 protein

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the expression level of serum microRNA-122,microRNA-21,S100A9,S100A8, TNF-α ,IL-1β and FSTL-1

  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)

Eligibility Criteria

• Age: 3 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children who needed elective parental liver transplantation due to biliary atresia from January 2020 to December 2022

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin First Central Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample 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)

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: March 2, 2023
• Study Start: August 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 16, 2023

Record last verified: 2023-05