Risk of Acute Kidney Injury in Pulmonary Endarterectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Perioperative Risk Assessment of Acute Kidney Injury Related to Pulmonary Endarterectomy Under Deep Hypothermic Circulatory Arrest
Overview
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.
Detailed description
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.
Primary outcome measures
- Occurrence of Acute Kidney Injury (AKI) after Pulmonary Endarterectomy (PEA) [Time frame: Within 7 days after PEA surgery]
Secondary outcome measures (6)
- Recovery of Renal Function [Time frame: 1 months after surgery]
- Use of Renal Replacement Therapy (RRT) survey [Time frame: Within 3 months after surgery]
- duration of postoperative dialysis or continuous renal replacement therapy (CRRT). [Time frame: Within 3 months after surgery]
- Changes in Estimated Glomerular Filtration Rate (eGFR) from Baseline to 3 Months Postoperatively [Time frame: 3 months after surgery]
- Progression to Chronic Kidney Disease (CKD) at 3 Months Postoperatively [Time frame: 3 months after surgery]
- Dynamic Changes of Neutrophil Gelatinase-Associated Lipocalin (NGAL) and Kidney Injury Molecule-1 (KIM-1) and Their Correlation with AKI Occurrence and Severity [Time frame: From preoperative to 72 hours postoperatively]
Eligibility criteria
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 .
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- China-Japan Friendship Hospital — Beijing
Identifiers
NCT: NCT07135206 · ZRYH-PEA-AKI-2025