Risk of Acute Kidney Injury in Pulmonary Endarterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

284 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2029-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to assess the perioperative risk factors for acute kidney injury (AKI) in patients undergoing pulmonary endarterectomy (PEA) with deep hypothermic circulatory arrest (DHCA). By analyzing retrospective data (2016-2025) from approximately 240 PEA patients and prospectively enrolling 44 patients (2025-2027), we will identify clinical risk factors, establish and validate a comprehensive prediction model, and explore the dynamic characteristics and predictive value of novel biomarkers (e.g., NGAL, KIM-1). The goal is to improve early warning and management of PEA-related AKI, thereby enhancing patient outcomes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Kidney Injury After PTE: Association With Hypothermic Circulatory Arrest Duration

NCT07132619

Acute Kidney Injury Acute Kidney Failure Pulmonary Thromboembolisms +1 more

COMPLETED

Risk Factors of Postoperative Acute Kidney Injury and Mortality Among Hospitalized Patients Undergoing Major Surgery

NCT07136194

Acute Kidney Injury Major Surgery Under General Anesthesia Mortality +2 more

COMPLETED

Early Prediction of Acute Kidney Injury in High Risk Patients After Non-cardiac Surgery

NCT03880110

Acute Kidney Injury

UNKNOWN

Evaluation of Postoperative Acute Kidney Injury (AKI) Incidence and Risk Factors in Patients Underwent Pneumonectomy

NCT05672238

Acute Kidney Injury Pneumonectomy; Status Complication,Postoperative

COMPLETED

Predictive Nomogram for Postoperative Acute Kidney Injury in Older Patients Undergoing Noncardiac Surgery

NCT05507268

Postoperative Acute Kidney Injury

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background: PEA is the radical treatment for chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary artery sarcoma, requiring DHCA to ensure a bloodless surgical field. However, AKI occurs in 10-49% of PEA patients, significantly higher than neurological injury, leading to prolonged hospitalization and increased mortality. The risk factors and predictive biomarkers for PEA-related AKI remain unclear, highlighting the need for this research.

Study Design: A single-center, dual-cohort study including:

Retrospective Cohort: Patients who underwent PEA at China-Japan Friendship Hospital from 2016 to 2025. Data on baseline characteristics, intraoperative parameters (CPB/DHCA duration, perfusion pressure), postoperative renal function (based on KDIGO criteria), and outcomes (e.g., renal replacement therapy) will be collected to identify risk factors.

Prospective Cohort: Patients scheduled for PEA from 2025 to 2027. Clinical data and biological samples (blood/urine) will be collected at multiple time points (preoperatively, 2h/6h during CPB, 0h/24h/72h postoperatively) to measure biomarkers (NGAL, KIM-1, Scr, BUN). This cohort will validate the prediction model and assess biomarker performance.

Objectives:

Identify independent risk factors for PEA-related AKI. Develop and validate a perioperative prediction model for AKI. Clarify the dynamic changes and diagnostic/predictive value of novel biomarkers.

Outcome Measures:

Primary: AKI occurrence (KDIGO criteria). Secondary: AKI recovery rate, renal replacement therapy usage, hospital stay, 3-month mortality, and changes in renal/cardiopulmonary function.

Significance: This study will fill gaps in perioperative renal protection for PEA, provide an evidence-based risk assessment tool, and lay the foundation for optimized clinical management.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Kidney Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PEA Patients with AKI Risk Assessment Cohort

This cohort integrates retrospective and prospective data from patients undergoing pulmonary endarterectomy (PEA) with deep hypothermic circulatory arrest (DHCA) at China-Japan Friendship Hospital. It includes: 1) Retrospective cases (2016-2025, \~240 cases) to explore perioperative risk factors for PEA-related acute kidney injury (AKI); 2) Prospective cases (2025-2027, 44 cases) to validate prediction models and analyze dynamic biomarkers (e.g., NGAL, KIM-1). The cohort aims to comprehensively assess AKI risk through combined analysis of historical and real-time data.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Clinical diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary artery sarcoma, and scheduled for or having undergone pulmonary endarterectomy (PEA) .

Aged 18 to 85 years . Underwent PEA using cardiopulmonary bypass (CPB) combined with deep hypothermic circulatory arrest (DHCA) technology .

Complete clinical data (including preoperative baseline data, intraoperative CPB/DHCA parameters, and postoperative respiratory, circulatory, and renal function data) .

Available renal function indicators at 3 months after surgery .

Exclusion Criteria

Receiving preoperative maintenance renal replacement therapy . Complicated with severe liver failure, end-stage malignant tumors, or other diseases that affect short-term prognosis .

Missing key data (e.g., CPB/DHCA duration, postoperative 72-hour serum creatinine \[Scr\]) that cannot be supplemented .

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No