Clinical Trials Directory

Trials / Completed

CompletedNCT07343830

Prediction of Acute Kidney Injury After Cardiac Surgery With Cardiopulmonary Bypass

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

Status
Completed
Phase
Study type
Observational
Enrollment
455 (actual)
Sponsor
Ataturk University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Timeline

Start date
2026-01-30
Primary completion
2026-02-02
Completion
2026-02-02
First posted
2026-01-15
Last updated
2026-02-04

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07343830. Inclusion in this directory is not an endorsement.