Clinical Trials Logo

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date December 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 3 Months to 5 Years
Eligibility Inclusion Criteria: - Patient was diagnosed with biliary atresia - American society of anesthesiologists physical status ?-? 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tianjin First Central Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)]
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05818644 - Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children
Not yet recruiting NCT06041490 - Adjuvant Therapy for High-risk Hepatocellular Carcinoma Post Liver Transplantation Phase 2
Recruiting NCT04443322 - Durvalumab and Lenvatinib in Participants With Locally Advanced and Metastatic Hepatocellular Carcinoma ( Dulect2020-1 ) N/A
Recruiting NCT05081141 - HHV8 and Solid Organ Transplantation
Completed NCT03165916 - Study to Compare the Incidence of Biliary Complications After Liver Transplantation N/A
Withdrawn NCT04216303 - Optimal A1c Control in Post Liver or Combined Liver and Kidney Transplant Recipients Who Have Diabetes Mellitus
Recruiting NCT04506398 - Heterogeneity and Evolution of hepatoceLlular Carcinoma in Post-transplant HCC Recurrence
Not yet recruiting NCT05853484 - Home-based Bimodal Lifestyle Intervention in Patients With Liver Cirrhosis Awaiting Orthotopic Liver Transplantation N/A
Not yet recruiting NCT05036031 - Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study
Recruiting NCT05065125 - Clinical Usefulness of Digital Single-operator Cholangioscopy(SpyGlass™) for Post-liver Transplant Anastomotic Stricture
Recruiting NCT06060392 - Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus N/A
Enrolling by invitation NCT05195944 - Semaglutide vs Sitagliptin Phase 4
Completed NCT05255510 - Risk of Acute Kidney Injury in Living Liver Donor Surgery
Not yet recruiting NCT06048445 - Placement of Biliary Drainage Stent to Prevent Biliary Intestinal Anastomosis After Liver Transplantation in Children
Completed NCT05116748 - COVID19 Vaccine in SOT Adult Recipients
Completed NCT04182256 - Magnetic Spiderman for Preparation of Liver Donation N/A
Recruiting NCT04327427 - Outcome Analysis of Aspirin in Liver Transplantation
Recruiting NCT04477967 - Design and Implementation of the Pediatric Liver Transplantation Biobank
Recruiting NCT05109156 - Preoperative Sepsis Timeline, Profile and Its Association With Recipient Outcome Following Live Donor Liver Transplant
Recruiting NCT06124209 - Use of Fibrin Sealant Patch for Vein Anastomosis During Deceased Donor Liver Transplantation- Randomized Clinical Trial Phase 4