Acute Kidney InjuryPEAAKINCT07135206
Risk of Acute Kidney Injury in Pulmonary Endarterectomy
An observational study of Acute Kidney Injury, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 284 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 30 Jul 2029
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary artery sarcoma who undergo pulmonary endarterectomy (PEA) with deep hypothermic circulatory arrest (DHCA) at China-Japan Friendship Hospital. The study aims to evaluate perioperative risk factors for PEA-related acute kidney injury (AKI) and the value of novel biomarkers 。
Who may be able to join
- 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 .
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yinghui Fang, M.D. contact
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Li Fang Wang Dr., MD, +8684205883, lilythewolf@sina.com
About this study
Official title: Perioperative Risk Assessment of Acute Kidney Injury Related to Pulmonary Endarterectomy Under Deep Hypothermic Circulatory Arrest
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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PEA Patients with AKI Risk Assessment Cohort | This cohort integrates retrospective and prospective data from patients undergoing pulmonary endarterectomy (PEA) with deep hypothermic circulatory arrest (DHCA) at China-Japan Friendship Hospital. It includes: 1) Retrospective cases (2016-2025, ~240 cases) to explore perioperative risk factors for PEA-related acute kidney injury (AKI); 2) Prospective cases (2025-2027, 44 cases) to validate prediction models and analyze dynamic biomarkers (e.g., NGAL, KIM-1). The cohort aims to comprehensively assess AKI risk through combined analysis of historical and real-time data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Acute Kidney Injury (AKI) after Pulmonary Endarterectomy (PEA)
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
Measured: Within 7 days after PEA surgery
Secondary outcomes (6)
Recovery of Renal Function
Proportion of patients whose Scr returns to ≤120% of baseline level before discharge.
Measured: 1 months after surgery
Use of Renal Replacement Therapy (RRT) survey
Incidence of postoperative dialysis or continuous renal replacement therapy (CRRT).
Measured: Within 3 months after surgery
duration of postoperative dialysis or continuous renal replacement therapy (CRRT).
Use of Renal Replacement Therapy (RRT)
Measured: Within 3 months after surgery
Changes in Estimated Glomerular Filtration Rate (eGFR) from Baseline to 3 Months Postoperatively
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).
Measured: 3 months after surgery
Progression to Chronic Kidney Disease (CKD) at 3 Months Postoperatively
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).
Measured: 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
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
Measured: From preoperative to 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 284 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Fang Wang, China-Japan Friendship Hospital
- Investigators
- Lifang Wang, M.D., Principal investigator, China-Japan Friendship Hospital, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135206
- Sponsor's protocol ID
- ZRYH-PEA-AKI-2025
- Acronym
- PEAAKI
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be shared with qualified researchers upon reasonable request, following publication of the study results. Shared data will include de-identified clinical information (baseline characteristics, intraoperative parameters, postoperative outcomes) and biomarker data, excluding direct identifiers to protect participant privacy. Data access will require approval from the institutional review board of China-Japan Friendship Hospital and a signed data use agreement specifying the purpose of use and confidentiality obligations. The data will be shared via a secure research data repository for up to 5 years after study completion
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Risk Assessment of Acute Kidney Injury Related to Pulmonary Endarterectomy Under Deep Hypothermic Circulatory Arrest
- ClinicalTrials.gov ID
- NCT07135206
- Acronym / sponsor ID
- PEAAKI / ZRYH-PEA-AKI-2025
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEA Patients with AKI Risk Assessment Cohort | – | –This cohort integrates retrospective and prospective data from patients undergoing pulmonary endarterectomy (PEA) with deep hypothermic circulatory arrest (DHCA) at China-Japan Friendship Hospital. It includes: 1) Retrospective cases (2016-2025, ~240 cases) to explore perioperative risk factors for PEA-related acute kidney injury (AKI); 2) Prospective cases (2025-2027, 44 cases) to validate prediction models and analyze dynamic biomarkers (e.g., NGAL, KIM-1). The cohort aims to comprehensively assess AKI risk through combined analysis of historical and real-time data. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary artery sarcoma who undergo pulmonary endarterectomy (PEA) with deep hypothermic circulatory arrest (DHCA) at China-Japan Friendship Hospital. The study aims to evaluate perioperative risk factors for PEA-related acute kidney injury (AKI) and the value of novel biomarkers 。
Key inclusion criteria (4 listed)
- 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 .
Key exclusion criteria (2 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be shared with qualified researchers upon reasonable request, following publication of the study results. Shared data will include de-identified clinical information (baseline characteristics, intraoperative parameters, postoperative outcomes) and biomarker data, excluding direct identifiers to protect participant privacy. Data access will require approval from the institutional review board of China-Japan Friendship Hospital and a signed data use agreement specifying the purpose of use and confidentiality obligations. The data will be shared via a secure research data repository for up to 5 years after study completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yinghui Fang, M.D. contact
Lifang Wang, M.D. principal investigator
China-Japan Friendship Hospital, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lifang Wang, M.D. (8601084205882, lilythewolf@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Acute Kidney Injury (AKI) after Pulmonary Endarterectomy (PEA) (time frame: Within 7 days after PEA surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.