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

NCT05807802 | Unknown DMC

• 1 other identifier: FSTL1 on PPC after LDLT
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the expression level of serum FSTL-1

  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)]

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children who needed elective parental liver transplantation due to biliary atresia

You may qualify if:

• Patient was diagnosed with biliary atresia
• American society of anesthesiologists physical status Ⅱ-Ⅲ

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin First Central Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample 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)

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: May 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 13, 2023

Record last verified: 2023-04