Acute Kidney InjuryNCT07132619
AKI After Pulmonary Endarterectomy
An observational study of Acute Kidney Injury and Acute Kidney Failure, run by Ebru Girgin Dinc at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Kidney Injury, Acute Kidney Failure, Pulmonary Thromboembolisms
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2024to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients aged 18-85 years
- Underwent pulmonary endarterectomy between 2018 and 2020
Who cannot join
- Age below 18 years
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kosuyolu Heart Training and Research Hospital
Istanbul, Kartal, 34846
About this study
Official title: Predictors and Outcomes of Acute Kidney Injury After Pulmonary Endarterectomy: A Single-Centre Retrospective Study
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.
Read the 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.
- 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
- Medical subject headings
- Acute Kidney Injury, Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 48 hours, postoperatively
Secondary outcomes (3)
Severity of Acute Kidney Injury According to KDIGO Staging
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.
Measured: up to 48 hours, postoperatively
Length of Intensive Care Unit Stay
Total number of days from the date of ICU admission immediately following surgery until discharge from the ICU.
Measured: up to 30 days postoperatively
In-Hospital Mortality
Death from any cause during the same hospitalization as the index pulmonary endarterectomy procedure.
Measured: up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start30 Jun 2024
- Primary completion30 Jun 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ebru Girgin Dinc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ebru Girgin Dinc, Koşuyolu Kartal Heart Training and Research Hospital
- Investigators
- Atakan ERKILINC, MD, Associate Professor, Principal investigator, University of Health Sciences, Kosuyolu Heart Training and Research Hospital, Kartal, ISTANBUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132619
- Sponsor's protocol ID
- AKI-PEA
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors and Outcomes of Acute Kidney Injury After Pulmonary Endarterectomy: A Single-Centre Retrospective Study
- ClinicalTrials.gov ID
- NCT07132619
- Acronym / sponsor ID
- AKI-PEA
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ebru Girgin DincUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients aged 18-85 years
- Underwent pulmonary endarterectomy between 2018 and 2020
Key exclusion criteria (2 listed)
- Age below 18 years
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Severity of Acute Kidney Injury According to KDIGO Staging
Time frame: up to 48 hours, postoperatively
Length of Intensive Care Unit Stay
Time frame: up to 30 days postoperatively
In-Hospital Mortality
Time frame: up to 30 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atakan ERKILINC, MD, Associate Professor principal investigator
University of Health Sciences, Kosuyolu Heart Training and Research Hospital, Kartal, ISTANBUL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Acute Kidney Failure, run by Ebru Girgin Dinc at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Perioperative Determinants of Postoperative Acute Kidney Injury (time frame: up to 48 hours, postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.