Kidney Injury After PTE: Association With Hypothermic Circulatory Arrest Duration

NCT ID: NCT07132619

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-08-01

Brief Summary

This retrospective, single-center observational study evaluates the association between the duration of total circulatory arrest (TCA) and the incidence and severity of postoperative acute kidney injury (AKI) in patients undergoing pulmonary endarterectomy between 2018 and 2020. AKI will be classified according to KDIGO 2012 criteria, using both changes in serum creatinine and hourly urine output tracked over 48 hours. The study aims to determine the frequency of AKI, its association with TCA duration, and to identify potential perioperative risk factors contributing to renal dysfunction. Secondary outcomes will include the relationship between AKI and in-hospital mortality, length of intensive care unit stay, and total hospital length of stay. Findings from this study may provide insights into optimizing intraoperative management strategies to reduce postoperative renal morbidity in patients undergoing pulmonary endarterectomy.

Detailed Description

Acute kidney injury (AKI) is a common and clinically significant complication following cardiothoracic surgery, particularly in procedures requiring circulatory arrest. Pulmonary endarterectomy (PEA), which is often performed under deep hypothermic total circulatory arrest (TCA), carries a notable risk for postoperative renal dysfunction due to ischemia-reperfusion injury and intraoperative hemodynamic instability. The reported incidence of AKI after PEA varies widely, ranging from 20% to 50%, and is associated with increased morbidity, prolonged hospitalization, and elevated mortality. Despite this clinical importance, few studies have systematically evaluated AKI in the setting of PEA using both serum creatinine and urine output criteria.

The 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines emphasize the use of both biomarkers in AKI diagnosis, yet most studies rely solely on creatinine. Given the limitations of isolated creatinine-based assessment, integrating hourly urine output offers a more comprehensive understanding of renal function. This study was designed to evaluate the relationship between TCA duration and the incidence and severity of AKI in patients undergoing PEA, using full KDIGO 2012 criteria. The goal was to better characterize AKI risk in this high-acuity population and inform perioperative management strategies.

Conditions

Acute Kidney Injury; Acute Kidney Failure; Pulmonary Thromboembolisms; Hypothermic Circulatory Arrest Time

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients aged 18-85 years
• Underwent pulmonary endarterectomy between 2018 and 2020

Exclusion Criteria

• Age below 18 years
• Pregnant women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ebru Girgin Dinc

OTHER

Sponsor Role: lead

Responsible Party

Ebru Girgin Dinc

M.D., Anesthesiologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Atakan ERKILINC, MD, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

University of Health Sciences, Kosuyolu Heart Training and Research Hospital, Kartal, ISTANBUL

Locations

Kosuyolu Heart Training and Research Hospital

Istanbul, Kartal, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HTCA-PEA

Identifier Type: -

Identifier Source: org_study_id