Risk of Acute Kidney Injury in Pulmonary Endarterectomy

NCT07135206 | Not Yet Recruiting DMC

• 1 other identifier: ZRYH-PEA-AKI-2025
• Study Type: observational
• Target: 284
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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

  Within 7 days after PEA surgery

Secondary Outcomes (6)

• Recovery of Renal Function

  1 months after surgery

• Use of Renal Replacement Therapy (RRT) survey

  Within 3 months after surgery

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

  Within 3 months after surgery

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

  3 months after surgery

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

  3 months after surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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 。

You may qualify if:

• 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 .

You may not qualify if:

• 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 .

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood (3mL per time point) and mid-stream urine (5mL per time point) will be collected. Serum and urine supernatant will be stored at -80℃ after centrifugation. Samples are used for detecting biomarkers such as NGAL and KIM-1, without DNA extraction.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Lifang Wang, M.D.

  China-Japan Friendship Hospital, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lifang Wang, M.D.

CONTACT

8601084205882; lilythewolf@sina.com

Yinghui Fang, M.D.

CONTACT

86-10-18810488373

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Li Fang Wang

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 22, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): July 30, 2029
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Individual participant data (IPD) and supporting information will be made available within 1 month after the publication of study results, with access maintained for 5 years after study completion.
• Access Criteria: Eligible researchers must submit a research application specifying the purpose of data use and research plan, which will be reviewed and approved by the Institutional Review Board of China-Japan Friendship Hospital.A data use agreement must be signed, committing to use the data solely for scientific research, protect participants' privacy, refrain from unauthorized data transfer, and cite this study in published outcomes.De-identified data will be accessible through the hospital's designated secure data repository.

Locations

CN (1)