Acute Lung InjuryNCT05752058
Risk Factors for Early Acute Lung Injury After Liver Transplantation in Children
An observational study of Acute Lung Injury and Liver Transplantation, run by Tianjin First Central Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 months to 2 years
- Conditions the study is for
- Acute Lung Injury, Liver Transplantation, Risk Factors
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Children who needed elective parental liver transplantation due to biliary atresia from January 2020 to December 2022
Who may be able to join
- patient was diagnosed with biliary atresia
- American society of anesthesiologists physical status Ⅱ-Ⅲ
Who cannot join
- 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
About this study
Official title: Risk Factors for Early Acute Lung Injury After Liver Transplantation in Children and the Prediction Vaulen
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.
- Conditions
- Acute Lung Injury, Liver Transplantation, Risk Factors
- Keywords
- Acute lung injury, liver transplantation, microRNAs, follistatins-like protein 1, S100A9 protein
- Medical subject headings
- Acute Lung Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Aug 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin First Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingli Cao, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752058
- Sponsor's protocol ID
- 2022N105KY
- Status last verified
- May 2023
- First submitted
- 12 Feb 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Early Acute Lung Injury After Liver Transplantation in Children and the Prediction Vaulen
- ClinicalTrials.gov ID
- NCT05752058
- Acronym / sponsor ID
- 2022N105KY
- Conditions
- Acute Lung Injury, Liver Transplantation, Risk Factors
- Keywords
- Acute lung injury, liver transplantation, microRNAs, follistatins-like protein 1, S100A9 protein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tianjin First Central HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children who needed elective parental liver transplantation due to biliary atresia from January 2020 to December 2022
Key inclusion criteria (2 listed)
- patient was diagnosed with biliary atresia
- American society of anesthesiologists physical status Ⅱ-Ⅲ
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the score of acute lung injury
Time frame: 1 week after liver transplantation
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 secondary outcome
the expression level of serum microRNA-122,microRNA-21,S100A9,S100A8, TNF-α ,IL-1β and FSTL-1
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lung Injury and Liver Transplantation, run by Tianjin First Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the score of acute lung injury (time frame: 1 week after liver transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.