NCT06218745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

January 22, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

January 12, 2024

Last Update Submit

July 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Hee Young Kim

    Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor for fund

Study Record Dates

First Submitted

January 12, 2024

First Posted

January 23, 2024

Study Start

January 22, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations