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

Recruiting

• Conditions: Lung Transplantation

• Registration Number: NCT06218745
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief 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.

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 Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-12
• Study Start: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-23
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

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

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Exclusion Criteria

• None.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative acute kidney injury (AKI)	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.

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Korea, Republic of