Lung TransplantationNCT06218745
Prediction Model for Postoperative AKI in Patients Undergoing Lung Transplantation Using Machine Learning
An observational study of Lung Transplantation, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
Since 1963, lung transplantation progress has surged due to immunosuppressive agent advancements. In 2004, 1,815 global lung transplantations were reported. Elderly recipients face impaired lung function and health instability, leading to potential respiratory complications post-surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- General anesthesia
- How many people
- 214 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jan 2024to 30 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients 18 years of age or older who underwent lung transplantation for end-stage lung disease
Who may be able to join
- Adult patients 18 years of age or older who underwent lung transplantation for end-stage lung disease
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction Model for Postoperative Acute Kidney Injury in Patients Undergoing Lung Transplantation Using Machine Learning: a Retrospective Cohort Study
Since 1963, lung transplantation progress has surged due to immunosuppressive agent advancements. In 2004, 1,815 global lung transplantations were reported. Elderly recipients face impaired lung function and health instability, leading to potential respiratory complications post-surgery.
Postoperative acute renal injury (AKI) can cause temporary or chronic dysfunction, increasing hospitalization, complications, and additional treatment needs. Various factors contribute to postoperative renal dysfunction after lung transplantation, including sustained hypoperfusion, bleeding, heart failure, acute myocardial infarction, pulmonary embolism, sepsis, and medications. Retrospective analysis of adult lung transplant patients' records aims to explore characteristics, anesthesia methods, intraoperative tests, and postoperative acute renal dysfunction, analyzing incidence and risk factors to develop a machine learning predictive model.
Read the detailed description
Since the first report of lung transplantation in humans in 1963, there has been rapid progress in both the quantity and quality of lung transplantation, driven by the significant advancements in immunosuppressive agents since the mid-1990s. In 2004, a total of 1,815 lung transplantations were reported worldwide. Patients undergoing lung transplantation are often elderly and face not only impaired lung function but also overall health instability, leading to the potential occurrence of respiratory complications post-surgery, even with successful lung transplantation outcomes.
Postoperative acute renal injury (AKI) can result in temporary or even chronic renal dysfunction. AKI following surgery can lead to an increase in hospitalization duration, complications, and the need for additional treatment. Various factors are associated with postoperative renal dysfunction after lung transplantation, including sustained hypoperfusion, hypoperfusion related to intraoperative and postoperative bleeding, heart failure, acute myocardial infarction, pulmonary embolism, sepsis, and more. Medications related to renal dysfunction include those associated with thrombosis or embolism, such as aminoglycosides, amphotericin B, non-steroidal anti-inflammatory drugs (NSAIDs), proton-pump inhibitors, contrast agents, and others. Additionally, graft-versus-host disease is known to be related to renal dysfunction.
The retrospective analysis of medical records from adult patients who underwent lung transplantation aims to investigate patient characteristics, anesthesia methods, intraoperative tests, and the occurrence of postoperative acute renal dysfunction. The goal is to analyze the incidence and risk factors of postoperative renal dysfunction and develop a predictive model through machine learning.
- Conditions
- Lung Transplantation
- Being tested
- General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaOther
General anesthesia using 2% propofol, and remifentanil for lung transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative acute kidney injury (AKI)
Diagnosis of postoperative AKI is based on the change in serum creatinine concentration within 48 hours after surgery.
Stage 1: An increase in serum creatinine of ≥ 0.3 mg/dL from baseline or a 1.5-2 times increase (≥ 1.5-2 times).
Stage 2: An increase in serum creatinine of > 2-3 times from baseline (> 2-3 times).
Stage 3: An increase in serum creatinine of ≥ 3 times from baseline or an increase to ≥ 4.0 mg/dL from baseline (≥ 4.0 mg/dL, only applicable if it increases by at least 0.5 mg/dL acutely), or initiation of renal replacement therapy.
Measured: Within 48 hours after lung transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start22 Jan 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Hee Young, Pusan National University Yangsan Hospital
- Investigators
- Hee Young Kim, Principal investigator, Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218745
- Sponsor's protocol ID
- 55-2024-003
- Status last verified
- Jul 2025
- First submitted
- 12 Jan 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Model for Postoperative Acute Kidney Injury in Patients Undergoing Lung Transplantation Using Machine Learning: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06218745
- Acronym / sponsor ID
- 55-2024-003
- Conditions
- Lung Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 23 Jan 2024 (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.
Since 1963, lung transplantation progress has surged due to immunosuppressive agent advancements. In 2004, 1,815 global lung transplantations were reported. Elderly recipients face impaired lung function and health instability, leading to potential respiratory complications post-surgery.
Postoperative acute renal injury (AKI) can cause temporary or chronic dysfunction, increasing hospitalization, complications, and additional treatment needs. Various factors contribute to postoperative renal dysfunction after lung transplantation, including sustained hypoperfusion, bleeding, heart failure, acute myocardial infarction, pulmonary embolism, sepsis, and medications. Retrospective analysis of adult lung transplant patients' records aims to explore characteristics, anesthesia methods, intraoperative tests, and postoperative acute renal dysfunction, analyzing incidence and risk factors to develop a machine learning predictive model.
Detailed description
Since the first report of lung transplantation in humans in 1963, there has been rapid progress in both the quantity and quality of lung transplantation, driven by the significant advancements in immunosuppressive agents since the mid-1990s. In 2004, a total of 1,815 lung transplantations were reported worldwide. Patients undergoing lung transplantation are often elderly and face not only impaired lung function but also overall health instability, leading to the potential occurrence of respiratory complications post-surgery, even with successful lung transplantation outcomes.
Postoperative acute renal injury (AKI) can result in temporary or even chronic renal dysfunction. AKI following surgery can lead to an increase in hospitalization duration, complications, and the need for additional treatment. Various factors are associated with postoperative renal dysfunction after lung transplantation, including sustained hypoperfusion, hypoperfusion related to intraoperative and postoperative bleeding, heart failure, acute myocardial infarction, pulmonary embolism, sepsis, and more. Medications related to renal dysfunction include those associated with thrombosis or embolism, such as aminoglycosides, amphotericin B, non-steroidal anti-inflammatory drugs (NSAIDs), proton-pump inhibitors, contrast agents, and others. Additionally, graft-versus-host disease is known to be related to renal dysfunction.
The retrospective analysis of medical records from adult patients who underwent lung transplantation aims to investigate patient characteristics, anesthesia methods, intraoperative tests, and the occurrence of postoperative acute renal dysfunction. The goal is to analyze the incidence and risk factors of postoperative renal dysfunction and develop a predictive model through machine learning.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients 18 years of age or older who underwent lung transplantation for end-stage lung disease
Key inclusion criteria (1 listed)
- Adult patients 18 years of age or older who underwent lung transplantation for end-stage lung disease
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anesthesiaGeneral anesthesia using 2% propofol, and remifentanil for lung transplantation | Other | – |
Primary outcome
Postoperative acute kidney injury (AKI)
Time frame: Within 48 hours after lung transplantation
Diagnosis of postoperative AKI is based on the change in serum creatinine concentration within 48 hours after surgery. Stage 1: An increase in serum creatinine of ≥ 0.3 mg/dL from baseline or a 1.5-2 times increase (≥ 1.5-2 times). Stage 2: An increase in serum creatinine of > 2-3 times from baseline (> 2-3 times). Stage 3: An increase in serum creatinine of ≥ 3 times from baseline or an increase to ≥ 4.0 mg/dL from baseline (≥ 4.0 mg/dL, only applicable if it increases by at least 0.5 mg/dL acutely), or initiation of renal replacement therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Hee Young Kim principal investigator
Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplantation, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative acute kidney injury (AKI) (time frame: Within 48 hours after lung 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 1 Aug 2025.