Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05807802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-13
First Post:
2023-03-29
Brief Title:
FSTL1 and PPCs on Pediatric Within LDLTa Prospective Cohort Analysis
Sponsor:
Tianjin First Central Hospital
Organization:
Tianjin First Central Hospital
Study Overview
Official Title:
Association Between FSTL1 and Postoperative Pulmonary Complications on Pediatric Within Living Donor Liver Transplantationa Prospective Cohort Analysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to identify the association between FSTL1 elevation and acute lung injury ALI after pediatric liver transplantationThe 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 ALIParticipants will be divided into non-ALI group and ALI group according to whether they had ALI in a week after liver transplantationResearchers will compare the difference between the two groups and use multivariate logistic regression analysis to screen the risk factors of ALI and receiver operating characteristicROC curve was used to evaluate the predictive efficacy of risk factors
Detailed Description:
Postoperative pulmonary complicationsPPC are complicated diseases with high morbidity and mortality for pediatric after living donor liver transplant LDLT Acute lung injuryALI after LDLT is a common and complex pulmonary complication it is leading causes of disability and deathboth in the acute and long-term postoperative period the identification of effective prediction model involved in ALI is urgent and highly demandedIn order to observe the effect of follistim like protein 1FSTL1 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 indicatorsThe 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None