FSTL1 and PPCs on Pediatric Within LDLT:a Prospective Cohort Analysis

Sponsor

Tianjin First Central Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05807802

Collaborator

(none)

400

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this observational study is to identify the association between FSTL1 elevation and acute lung injury (ALI) after pediatric liver transplantation.The main questions it aims to answer what the risk factors are for 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) Pulmonary Complication Liver Transplant; Complications

Detailed Description

Postoperative pulmonary complications(PPC) are complicated diseases with high morbidity and mortality for pediatric after living donor liver transplant (LDLT), Acute lung injury(ALI) after LDLT is a common and complex pulmonary complication, it is leading causes of disability and death,both in the acute and long-term postoperative period, the identification of effective prediction model involved in ALI is urgent and highly demanded.In order to observe the effect of follistim like protein 1(FSTL1) on the incidence of ALI who underwent LDLT, and explore the related mechanism, the investigators aim to collect more than 400 infant patients underwent LDLT from May 2023 to December 2023 in our single-center prospective study. 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 FSTL1 were recorded immediately after induction of anesthesia (T1), 10 minutes at anhepatic stage (T2), 30 minutes at new hepatic stage (T3) and immediately after abdominal closure (T4). Murray score was used to determine whether ALI occurred one week after LDLT, and the children were divided into non-ALI group and ALI group. Postoperative mechanical ventilation time, ICU stay time, total length of hospital stay and mortality during hospitalization are recorded.

The primary outcome utilised a regression approach to adjust for potential confounders associated with ALI and FSTL1. 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 Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Association Between FSTL1 and Postoperative Pulmonary Complications on Pediatric Within Living Donor Liver Transplantation:a Prospective Cohort Analysis

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Outcome Measures

Primary Outcome Measures

the incidence of acute lung injury [1 week after living donor liver transplantation]
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.

Secondary Outcome Measures

the expression level of serum FSTL-1 [immediately after induction of anesthesia (T1), 10 minutes at anhepatic stage (T2), 30 minutes at new hepatic stage (T3) and immediately after abdominal closure (T4)]]
Real-time fluorescence quantitative polymerase chain reaction (RT-qPCR) was used to detect the expression of FSTL-1 in serum

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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