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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Transplant; Complications; Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS); Pulmonary Complication

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 Type: Observational
• Enrollment (Anticipated): 400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children who needed elective parental liver transplantation due to biliary atresia

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence 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 living donor liver transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the expression level of serum FSTL-1	Real-time fluorescence quantitative polymerase chain reaction (RT-qPCR) was used to detect the expression of FSTL-1 in serum	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)]

Collaborators and Investigators

• Sponsor: Tianjin First Central Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: living donor liver transplantation; pulmonary complication; follistatins-like protein 1
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: FSTL1 on PPC after LDLT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No