Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05807802 |
Other study ID # |
FSTL1 on PPC after LDLT |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 1, 2023 |
Est. completion date |
December 31, 2024 |
Study information
Verified date |
April 2023 |
Source |
Tianjin First Central Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.