Prediction Model for Postoperative AKI in Patients Undergoing Lung Transplantation Using Machine Learning

Lung Transplantation Clinical Trial

Official title:

Prediction Model for Postoperative Acute Kidney Injury in Patients Undergoing Lung Transplantation Using Machine Learning: a Retrospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218745
• Other study ID #: 55-2024-003
• Status: Recruiting
• Start date: January 22, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Pusan National University Yangsan Hospital
• Contact: Hee Young Kim, MD, PhD
• Phone: 82-10-7641-1774
• Email: anekhy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients 18 years of age or older who underwent lung transplantation for end-stage lung disease

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

Other:
• General anesthesia
General anesthesia using 2% propofol, and remifentanil for lung transplantation

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 48 hours after lung transplantation