Kidney Injury After PTE: Association With Hypothermic Circulatory Arrest Duration

NCT07132619 | Completed DMC

• 1 other identifier: HTCA-PEA
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

AKI; Acute Kıdney Injury; PTE; Pulmonary Thromboembolisms; TCA; Hypothermic Circulatory Arrest Time

Outcome Measures

Primary Outcomes (1)

• Association Between Total Circulatory Arrest Duration and Incidence of Postoperative Acute Kidney Injury

  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).

  up to 48 hours, postoperatively

Secondary Outcomes (3)

• Severity of Acute Kidney Injury According to KDIGO Staging

  up to 48 hours, postoperatively

• Length of Intensive Care Unit Stay

  up to 30 days postoperatively

• In-Hospital Mortality

  up to 30 days postoperatively

Eligibility Criteria

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

Study Population

This study will include adult patients aged 18 to 85 years who underwent pulmonary endarterectomy at the Cardiothoracic Surgery Unit of Kosuyolu Kartal Heart Training and Research Hospital (Kosuyolu KHTRH), a single tertiary referral center in Istanbul, Turkey, between January 1, 2018, and December 31, 2020. Patients meeting the inclusion criteria will have complete perioperative data available, including total circulatory arrest duration and postoperative renal function parameters. Individuals younger than 18 years of age and pregnant women at the time of surgery will be excluded.

You may qualify if:

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

You may not qualify if:

• Age below 18 years
• Pregnant women

Sponsors & Collaborators

• Ebru Girgin Dinc: lead

Study Sites (1)

Kosuyolu Heart Training and Research Hospital

Istanbul, Kartal, 34846, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Kidney Injury; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Atakan ERKILINC, MD, Associate Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Anesthesiologist

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 20, 2025
• Study Start: June 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 1, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)