Risk of Acute Kidney Injury in Pulmonary Endarterectomy

NCT07135206 · tracked via the Priya Life Science Japan tracker

Sponsor

China-Japan Friendship Hospital

Phase

Observational

Started

2026-01-01

Last updated

2025-08-22

Condition(s) studied

Acute Kidney Injury

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

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 .

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
China-Japan Friendship Hospital	Beijing	Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07135206 on ClinicalTrials.gov ↗ ← All trials in Japan