Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07135206

Risk of Acute Kidney Injury in Pulmonary Endarterectomy

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location contact

Li Fang Wang Dr., MD

CONTACT

[email protected]

+8684205883

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Primary outcomes

  1. Occurrence of Acute Kidney Injury (AKI) after Pulmonary Endarterectomy (PEA)

    Time frame: 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 outcomes

  1. Recovery of Renal Function

    Time frame: 1 months after surgery

    Proportion of patients whose Scr returns to ≤120% of baseline level before discharge.

  2. Use of Renal Replacement Therapy (RRT) survey

    Time frame: Within 3 months after surgery

    Incidence of postoperative dialysis or continuous renal replacement therapy (CRRT).

  3. duration of postoperative dialysis or continuous renal replacement therapy (CRRT).

    Time frame: Within 3 months after surgery

    Use of Renal Replacement Therapy (RRT)

  4. Changes in Estimated Glomerular Filtration Rate (eGFR) from Baseline to 3 Months Postoperatively

    Time frame: 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).

  5. Progression to Chronic Kidney Disease (CKD) at 3 Months Postoperatively

    Time frame: 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).

  6. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Lifang Wang, M.D.

CONTACT

[email protected]

8601084205882

Yinghui Fang, M.D.

CONTACT

86-10-18810488373

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

Perioperative Risk Assessment of Acute Kidney Injury Related to Pulmonary Endarterectomy Under Deep Hypothermic Circulatory Arrest

Acronym: PEAAKI

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.