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NCT Number: NCT07132619

AKI After Pulmonary Endarterectomy

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.

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Key information

Conditions

Acute Kidney Injury Acute Kidney Failure Cardiovascular Diseases Embolism Embolism and Thrombosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypothermic Circulatory Arrest Time Kidney Diseases Lung Diseases Male Urogenital Diseases Pulmonary Embolism Pulmonary Thromboembolisms Renal Insufficiency Respiratory Tract Diseases Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kosuyolu Heart Training and Research Hospital

Istanbul, Kartal, 34846, Turkey (Türkiye)

About this study

Pulmonary endarterectomy (PEA) is the established curative treatment for chronic thromboembolic pulmonary hypertension (CTEPH). Despite favourable haemodynamic outcomes, postoperative acute kidney injury (AKI) is a frequent and clinically relevant complication, reported in 7.1% to 57.5% of PEA series.

This retrospective observational study was conducted at a tertiary referral centre for PEA. Of 126 consecutive adult patients screened between January 2018 and December 2020, 117 were included in the primary analysis after applying predefined exclusion criteria and excluding one patient with insufficient postoperative renal data for KDIGO staging.

AKI was defined according to KDIGO 2012 criteria using both serum creatinine and urine output assessed over 48 hours. Four separate multivariable logistic regression models were constructed: Model A assessed preoperative variables; Model B assessed intraoperative time variables including ECC duration, DHCA duration and ACC time entered simultaneously; Model C assessed clinical and postoperative variables; and Model D was a parsimonious combined model incorporating variables identified as independent determinants across Models A through C.

Model discrimination was evaluated using receiver operating characteristic analysis with 95% confidence intervals estimated by non-parametric bootstrapping. Model calibration was assessed using the Hosmer-Lemeshow test, and bootstrap internal validation with 1000 resamples was used to estimate optimism-corrected AUC for the combined model. Linearity of the association between ECC duration and AKI was examined using restricted cubic spline modelling.

ECC duration, rather than DHCA or aortic cross-clamp duration, was the intraoperative time variable independently associated with AKI. Age was the principal preoperative determinant, and early postoperative albumin was independently associated with lower AKI odds. Despite comparable haemodynamic improvement in both groups, 30-day mortality was significantly higher in patients who developed AKI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age below 18 years
  • Pregnant women

Treatment and study plan

Primary outcomes

  1. Incidence and Perioperative Determinants of Postoperative Acute Kidney Injury

    Time frame: up to 48 hours, postoperatively

    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.

Secondary outcomes

  1. Severity of Acute Kidney Injury According to KDIGO Staging

    Time frame: 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.

  2. Length of Intensive Care Unit Stay

    Time frame: up to 30 days postoperatively

    Total number of days from the date of ICU admission immediately following surgery until discharge from the ICU.

  3. In-Hospital Mortality

    Time frame: up to 30 days postoperatively

    Death from any cause during the same hospitalization as the index pulmonary endarterectomy procedure.

Sponsors and collaborators

Lead sponsor

Ebru Girgin Dinc

Other

Registry information

Official study title

Predictors and Outcomes of Acute Kidney Injury After Pulmonary Endarterectomy: A Single-Centre Retrospective Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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