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AKI After Pulmonary Endarterectomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07132619
Enrollment
150
Registered
2025-08-20
Start date
2024-06-30
Completion date
2025-08-01
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

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.

Interventions

None listed

Sponsors

Ebru Girgin Dinc
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Age below 18 years * Pregnant women

Design outcomes

Primary

MeasureTime frameDescription
Incidence and Perioperative Determinants of Postoperative Acute Kidney Injuryup to 48 hours, postoperativelyThe 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

MeasureTime frameDescription
Severity of Acute Kidney Injury According to KDIGO Stagingup to 48 hours, postoperativelySeverity 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 Stayup to 30 days postoperativelyTotal number of days from the date of ICU admission immediately following surgery until discharge from the ICU.
In-Hospital Mortalityup to 30 days postoperativelyDeath from any cause during the same hospitalization as the index pulmonary endarterectomy procedure.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORAtakan ERKILINC, MD, Associate Professor

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026