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Not yet recruitingNCT05752058Updated May 16, 2023

Risk Factors for Early Acute Lung Injury After Liver Transplantation in Children

An observational study in Acute Lung Injury, Liver Transplantation and Risk Factors, sponsored by Tianjin First Central Hospital. Not yet recruiting. Open to participants aged 3 Months to 2 Years. Per ClinicalTrials.gov, last updated 2023-05-16.

Sponsored by Tianjin First Central Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
300
Ages
3 Months to 2 Years
Sex
All
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Study summary

The goal of this observational study is to identify the risk factors for early acute lung injury (ALI) after liver transplantation in children .The main questions it aims to answer are what the risk factors are for early 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.

Read the detailed description

The goal of this observational study is to identify the risk factors for early acute lung injury (ALI) after liver transplantation in children and evaluate the predictive value for the development of ALI.Perioperative data of patients were obtained through electronic case information management system, anesthesia surgery clinical information system and clinical research database. 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 microRNA-122, microRNA-21, S100A9,S100A8 ,follistim like protein 1(FSTL1), tumor necrosis factor-α (TNF-α) and interleukin-1β(IL-1β) were recorded immediately after induction of anesthesia (T1), 10 min at anhepatic stage (T2), 30 min at new hepatic stage (T3) and immediately after abdominal closure (T4). Intraoperative fluid intake and outflow, ALT, AST, and serum bilirubin peaks in the first week after surgery were recorded.Murray score was used to determine whether ALI occurred one week after surgery, and the children were divided into non-ALI group and ALI group. 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.

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Conditions studied

  • Acute Lung Injury
  • Liver Transplantation
  • Risk Factors

Keywords

  • Acute lung injury
  • liver transplantation
  • microRNAs
  • follistatins-like protein 1
  • S100A9 protein
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In context

Lung Injury

399 studies on the registry are indexed under Lung Injury; 50 are open to participants now.

This study's planned enrollment of 300 is above the median of 70 across 136 observational studies indexed under Lung Injury.

Browse Lung Injury studies →

Lead sponsor

Tianjin First Central Hospital is the lead sponsor of 18 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Months to 2 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children who needed elective parental liver transplantation due to biliary atresia from January 2020 to December 2022

Inclusion criteria

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

Exclusion criteria

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
  • Incomplete data
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. the score 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.

    Time frame: 1 week after liver transplantation

Secondary outcomes

  1. the expression level of serum microRNA-122,microRNA-21,S100A9,S100A8, TNF-α ,IL-1β and FSTL-1

    Real-time fluorescence quantitative polymerase chain reaction (RT-qPCR) was used to detect the expression of microRNA-122,microRNA-21,S100A9,S100A8,TNF-α ,IL-1β and FSTL-1 in serum.

    Time frame: immediately after induction of anesthesia (T1), 10 min at anhepatic stage (T2), 30 min at new hepatic stage (T3) and immediately after abdominal closure (T4)

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05752058
Lead sponsor
Tianjin First Central Hospital
Responsible party
Yingli Cao (Principal investigator, Tianjin First Central Hospital) — Principal investigator
First posted
Mar 2, 2023
Start date
Aug 1, 2023 (estimated)
Primary completion
Sep 30, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
May 16, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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