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临床试验/NCT07343830
NCT07343830已完成不适用

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

Ataturk University1 个研究点 分布在 1 个国家目标入组 455 人开始时间: 2026年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
455
试验地点
1
主要终点
Postoperative Acute Kidney Injury

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Postoperative AKI

Patients who developed acute kidney injury within 72 hours after cardiac surgery under cardiopulmonary bypass, defined according to the KDIGO serum creatinine criteria.

No Postoperative AKI

Patients who did not develop acute kidney injury within 72 hours after cardiac surgery under cardiopulmonary bypass according to the KDIGO serum creatinine criteria.

结局指标

主要结局

Postoperative Acute Kidney Injury

时间窗: 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.

次要结局

  • Severity of postoperative AKI (KDIGO stage)(Within 72 hours after cardiac surgery (postoperative days 0-3); assessed using the highest serum creatinine value measured every 12 hours (6 measurements))
  • In-Hospital Mortality(From the date of cardiac surgery through hospital discharge (index hospitalization), assessed at hospital discharge (up to 90 days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Akif Yilmaz

Principal Investigator

Ataturk University

研究点 (1)

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