AKI After Pulmonary Endarterectomy

NCT07132619 | Completed DMC

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

Brief Summary

This retrospective, single-centre observational study evaluates perioperative determinants and clinical outcomes of postoperative acute kidney injury (AKI) in patients undergoing pulmonary endarterectomy (PEA) between 2018 and 2020. AKI is classified according to KDIGO 2012 criteria using both serum creatinine changes and urine output over 48 hours. Preoperative, intraoperative and postoperative variables are assessed using multivariable logistic regression. Intraoperative time variables - including extracorporeal circulation (ECC) duration, deep hypothermic circulatory arrest (DHCA) duration and aortic cross-clamp time - are entered simultaneously to identify which component independently captures renal risk. The study also evaluates a parsimonious multivariable risk-stratification model based on routinely available perioperative data. Secondary outcomes include 30-day mortality, intensive care unit stay, hospital length of stay and renal replacement therapy requirement. Findings from this study may provide insights into perioperative risk stratification and renal monitoring strategies 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)

• Incidence and Perioperative Determinants of Postoperative Acute Kidney Injury

  The primary outcome is the occurrence of postoperative acute kidney injury (AKI) within 48 hours of surgery, defined according to KDIGO 2012 criteria using both serum creatinine changes from baseline and hourly urine output. AKI is analysed as a binary variable (yes/no) and further classified by severity stage (1, 2 or 3). Independent perioperative determinants of AKI - including extracorporeal circulation duration, deep hypothermic circulatory arrest duration, aortic cross-clamp time, age and early postoperative albumin - are assessed using multivariable logistic regression.

  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: June 10, 2026

Record last verified: 2025-08

Data Sharing

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

Locations

TU (1)