Risk of Acute Kidney Injury in Pulmonary Endarterectomy

Not yet recruiting

• Conditions: Acute Kidney Injury

• Registration Number: NCT07135206
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-20
• Last Update Submitted: 2025-08-20
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Study Start: 2026-01-01
• Primary Completion: 2028-12-31
• Study Completion: 2029-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 284

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 .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of Acute Kidney Injury (AKI) after Pulmonary Endarterectomy (PEA)	Within 7 days after PEA surgery	Acute kidney injury is defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria, which includes three stages based on serum creatinine (Scr) elevation and urine output reduction. Scr\>1.5 times baseline or ≥0.3 mg/dl increase, or urine output \<0.5 ml/kg/h for 6-12h

Secondary Outcome Measures

Name	Time	Method
Recovery of Renal Function	1 months after surgery	Proportion of patients whose Scr returns to ≤120% of baseline level before discharge.
Use of Renal Replacement Therapy (RRT) survey	Within 3 months after surgery	Incidence of postoperative dialysis or continuous renal replacement therapy (CRRT).
Changes in Estimated Glomerular Filtration Rate (eGFR) from Baseline to 3 Months Postoperatively	3 months after surgery	This outcome assesses the numerical change in estimated glomerular filtration rate (eGFR) of patients from preoperative baseline to 3 months after surgery. eGFR will be calculated using a clinically validated formula (e.g., CKD-EPI formula), with the unit of mL/(min·1.73 m²).
duration of postoperative dialysis or continuous renal replacement therapy (CRRT).	Within 3 months after surgery	Use of Renal Replacement Therapy (RRT)
Progression to Chronic Kidney Disease (CKD) at 3 Months Postoperatively	3 months after surgery	This outcome evaluates whether patients progress to chronic kidney disease (CKD) 3 months after surgery. CKD is defined as a persistent estimated glomerular filtration rate (eGFR) \< 60 mL/(min·1.73 m²) for ≥ 3 months (meeting the standard CKD diagnostic criteria). The assessment result is a categorical variable (Yes/No) (i.e., whether the patient progresses to CKD).
Dynamic Changes of Neutrophil Gelatinase-Associated Lipocalin (NGAL) and Kidney Injury Molecule-1 (KIM-1) and Their Correlation with AKI Occurrence and Severity	From preoperative to 72 hours postoperatively	This outcome focuses on detecting the levels of two novel biomarkers-neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1)-in serum and urine samples collected from patients at multiple predefined time points. The sampling time points include the preoperative period, 2 hours and 6 hours during cardiopulmonary bypass (CPB), and 0 hours, 24 hours, and 72 hours postoperatively. Additionally, this outcome will analyze the correlation between the dynamic changes in NGAL and KIM-1 levels and two key indicators of AKI: the occurrence of AKI (as defined by KDIGO criteria) and the severity of AKI (KDIGO Stage I, II, or III). Biospecimens (3ml venous blood and 5ml midstream urine per time point) will be processed by centrifugation, with serum and urine supernatant stored at -80°C before biomarker detection, and no DNA extraction will be performed on the samples

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China