Kidney Injury After PTE: Association With Hypothermic Circulatory Arrest Duration

Completed

• Conditions: Acute Kidney Injury; Acute Kidney Failure; Pulmonary Thromboembolisms; Hypothermic Circulatory Arrest Time

• Registration Number: NCT07132619
• Lead Sponsor: Ebru Girgin Dinc

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.

Study Timeline

• Study Start: 2024-06-30
• Primary Completion: 2025-06-30
• Status Verified: 2025-08
• Study Completion: 2025-08-01
• Study First Submitted: 2025-08-13
• Study First Submitted QC: 2025-08-13
• Last Update Submitted: 2025-08-13
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

• Age below 18 years
• Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association Between Total Circulatory Arrest Duration and Incidence of Postoperative Acute Kidney Injury	up to 48 hours, postoperatively	The presence or absence of postoperative acute kidney injury (AKI) will be determined according to KDIGO 2012 criteria, based on both changes in serum creatinine and hourly urine output within the first 48 hours after surgery. The primary measure will be the relationship between total circulatory arrest (TCA) duration (in minutes) and the occurrence of AKI, analyzed as a binary variable (yes/no).

Secondary Outcome Measures

Name	Time	Method
Severity of Acute Kidney Injury According to KDIGO Staging	up to 48 hours, postoperatively	Severity of postoperative acute kidney injury (AKI) will be graded according to KDIGO 2012 criteria (Stages 1-3) using both changes in serum creatinine and hourly urine output within the first 48 hours after surgery.
Length of Intensive Care Unit Stay	up to 30 days postoperatively	Total number of days from the date of ICU admission immediately following surgery until discharge from the ICU.
In-Hospital Mortality	up to 30 days postoperatively	Death from any cause during the same hospitalization as the index pulmonary endarterectomy procedure.

Trial Locations

Locations (1)

Kosuyolu Heart Training and Research Hospital; 🇹🇷 Istanbul, Kartal, Turkey