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NCT Number: NCT07343830

Prediction of Acute Kidney Injury After Cardiac Surgery With Cardiopulmonary Bypass

Acute kidney injury (AKI) is a common and serious complication following cardiac surgery performed under cardiopulmonary bypass and is associated with increased morbidity, mortality, and prolonged hospital stay. Despite advances in perioperative management, the ability to accurately predict postoperative AKI remains limited.

Recent evidence suggests that preoperative inflammatory markers derived from routine laboratory tests, as well as indicators of intraoperative perfusion stress, may play an important role in the development of AKI. However, data evaluating these factors together in patients undergoing cardiac surgery with cardiopulmonary bypass are limited.

This retrospective observational cohort study aims to investigate the association between preoperative renal function, inflammatory indices, and intraoperative perfusion-related parameters with the development of postoperative AKI. Acute kidney injury will be defined according to the KDIGO serum creatinine criteria within the first 72 hours after surgery. The findings of this study may help identify patients at increased risk for AKI and contribute to improved perioperative risk stratification in cardiac surgery.

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Key information

About this study

Acute kidney injury (AKI) is a frequent complication after cardiac surgery performed under cardiopulmonary bypass (CPB) and represents a major determinant of short- and long-term adverse outcomes. The pathophysiology of postoperative AKI is multifactorial and involves hemodilution, non-pulsatile flow, ischemia-reperfusion injury, systemic inflammatory response, and alterations in renal perfusion during CPB. Despite similar surgical and anesthetic management, not all patients develop AKI, suggesting that preoperative patient-related factors and intraoperative perfusion stress play a critical role.

In recent years, easily accessible inflammatory indices derived from routine hematological and biochemical parameters, such as the neutrophil-to-lymphocyte ratio, systemic immune-inflammation index, and C-reactive protein to albumin ratio, have been proposed as potential predictors of postoperative complications, including AKI. In addition, intraoperative parameters reflecting perfusion stress, such as cardiopulmonary bypass duration, arterial lactate levels, and acid-base disturbances, may further contribute to renal injury. However, studies evaluating these factors together in the setting of cardiac surgery with CPB are limited.

This single-center, retrospective observational cohort study will include adult patients who underwent cardiac surgery under cardiopulmonary bypass. Demographic data, comorbidities, preoperative laboratory parameters, echocardiographic findings, and intraoperative CPB-related variables will be collected retrospectively from institutional medical records. Acute kidney injury will be defined and staged according to the KDIGO serum creatinine criteria within 48-72 hours after surgery. Urine output criteria will not be evaluated due to limitations inherent to retrospective data collection.

The primary objective of the study is to identify independent predictors of postoperative AKI by assessing the combined effects of preoperative renal function, inflammatory markers, and intraoperative perfusion stress parameters. Secondary objectives include evaluation of AKI severity and in-hospital mortality. Multivariable logistic regression and receiver operating characteristic analyses will be used to determine the predictive value of selected parameters.

By improving understanding of the factors associated with postoperative AKI, this study aims to support better perioperative risk stratification and inform future prospective investigations in patients undergoing cardiac surgery with cardiopulmonary bypass.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 18 years or older
  • Patients who underwent cardiac surgery under cardiopulmonary bypass
  • Coronary artery bypass grafting, valve surgery, or combined cardiac surgery
  • Elective or emergency procedures

Exclusion criteria

  • Preoperative end-stage renal disease requiring dialysis
  • Preoperative serum creatinine level greater than 4.0 mg/dL
  • Off-pump cardiac surgery
  • Missing preoperative or postoperative serum creatinine data

Treatment and study plan

Primary outcomes

  1. Postoperative Acute Kidney Injury

    Time frame: Within 72 hours after cardiac surgery

    Development of acute kidney injury within 72 hours after cardiac surgery performed under cardiopulmonary bypass. Acute kidney injury will be defined according to the KDIGO serum creatinine criteria, based on an increase in serum creatinine of ≥0.3 mg/dL within 48 hours or ≥1.5 times baseline within 7 days. Urine output criteria will not be evaluated due to the retrospective nature of the study.

Secondary outcomes

  1. Severity of postoperative AKI (KDIGO stage)

    Time frame: Within 72 hours after cardiac surgery (postoperative days 0-3); assessed using the highest serum creatinine value measured every 12 hours (6 measurements)

    AKI severity will be classified as KDIGO Stage 1-3 based on the change between preoperative creatinine (measured within 48 hours preoperatively) and the highest postoperative serum creatinine within the first 72 hours

  2. In-Hospital Mortality

    Time frame: From the date of cardiac surgery through hospital discharge (index hospitalization), assessed at hospital discharge (up to 90 days)

    All-cause mortality during the index hospitalization following cardiac surgery, determined from hospital records

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

The Role of Preoperative Inflammation Markers, Renal Function, and Perfusion Stress in Predicting Acute Kidney Injury After Cardiac Surgery Under Cardiopulmonary Bypass: A Retrospective Cohort Study

Acronym: AKI-CPB

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Feb 4, 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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