Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 5:44 PM
Study NCT ID:
NCT07135206
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk of Acute Kidney Injury in Pulmonary Endarterectomy
Sponsor:
China-Japan Friendship Hospital
Organization:
Study Overview
Official Title:
Perioperative Risk Assessment of Acute Kidney Injury Related to Pulmonary Endarterectomy Under Deep Hypothermic Circulatory Arrest
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEAAKI
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 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: