Skip to content

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05807802
Enrollment
400
Registered
2023-04-11
Start date
2023-05-01
Completion date
2024-12-31
Last updated
2023-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Liver Transplant; Complications, Pulmonary Complication

Keywords

follistatins-like protein 1, pulmonary complication, living donor liver transplantation

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.

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.

Interventions

None listed

Sponsors

Tianjin First Central Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Months to 5 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the incidence of acute lung injury1 week after living donor liver transplantationMurray 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

MeasureTime frameDescription
the expression level of serum FSTL-1immediately 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026