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临床试验/NCT07582393
NCT07582393已完成不适用

Effectiveness of Renal Near-Infrared Spectroscopy Monitoring in Evaluating Postoperative Acute Kidney Injury in Patients Undergoing Elective Cardiac Surgery With Cardiopulmonary Bypass

SERAY TÜRKMEN1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2025年5月12日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
113
试验地点
1

研究概览

简要总结

This prospective observational study aims to evaluate the effectiveness of renal near-infrared spectroscopy (NIRS) monitoring in predicting postoperative acute kidney injury (AKI) in patients undergoing elective cardiac surgery with cardiopulmonary bypass. Acute kidney injury is a common and serious complication after cardiac surgery and is associated with increased morbidity and mortality.

A total of 115 adult patients scheduled for elective coronary artery bypass grafting or heart valve surgery using cardiopulmonary bypass will be included in the study. Renal and cerebral tissue oxygen saturation will be continuously monitored intraoperatively using near-infrared spectroscopy. Hemodynamic parameters, operative variables, and laboratory results will also be recorded.

Postoperative kidney function will be evaluated according to KDIGO criteria based on serum creatinine levels and urine output. Patients will be classified into two groups according to the presence or absence of postoperative acute kidney injury.

The aim of this study is to investigate whether intraoperative renal NIRS monitoring can be used as an early indicator for the development of acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass.

详细描述

Acute kidney injury (AKI) is one of the most common complications following cardiac surgery performed with cardiopulmonary bypass and is associated with increased morbidity, prolonged intensive care unit stay, and higher mortality rates. Early detection of renal hypoperfusion during surgery may allow timely interventions to prevent postoperative kidney injury. Near-infrared spectroscopy (NIRS) provides non-invasive and continuous monitoring of regional tissue oxygen saturation and may be useful for detecting renal tissue hypoxia during cardiac surgery.

The aim of this prospective observational study is to investigate the effectiveness of intraoperative renal NIRS monitoring in predicting postoperative acute kidney injury in patients undergoing elective cardiac surgery with cardiopulmonary bypass.

The study will be conducted in the operating rooms of Istanbul Prof. Dr. Cemil Tascioglu City Hospital. A total of 115 adult patients scheduled for elective coronary artery bypass graft surgery or heart valve repair or replacement with the use of cardiopulmonary bypass will be included. Patients younger than 18 years, those with a body mass index greater than 35 kg/m², preoperative renal dysfunction, preoperative inotropic support, mechanical ventilation requirement, acute coronary syndrome requiring urgent intervention, or acute aortic dissection will be excluded from the study.

Before surgery, demographic data including age, sex, body mass index, comorbidities, previous surgeries, ejection fraction, and current medications will be recorded. Laboratory parameters including hemoglobin, creatinine, glomerular filtration rate, bilirubin levels, and lactate dehydrogenase will also be collected. Risk scores including ASA classification, Charlson Comorbidity Index, and EuroSCORE II will be calculated.

Renal and cerebral tissue oxygen saturation will be continuously monitored intraoperatively using a near-infrared spectroscopy device (Masimo Root® with O3® Regional Oximetry). Sensors will be placed over the renal regions determined by ultrasonographic localization before surgery. Hemodynamic parameters, arterial blood gas values, and intraoperative variables will be recorded at predefined time points during anesthesia induction, cardiopulmonary bypass, and after separation from cardiopulmonary bypass.

研究设计

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

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

  • Age ≥18 years
  • Patients undergoing elective cardiac surgery with cardiopulmonary bypass
  • Written informed consent obtained
  • Body mass index <35 kg/m²
  • Estimated glomerular filtration rate >65 mL/min/1.73 m²

排除标准

  • Refusal to participate
  • Age <18 years
  • Body mass index ≥35 kg/m²
  • Skin-to-kidney capsule distance >4.5 cm
  • Estimated glomerular filtration rate <65 mL/min/1.73 m²
  • Preoperative inotropic support
  • Preoperative mechanical ventilation
  • STEMI or NSTEMI requiring contrast administration
  • Planned total circulatory arrest
  • Acute aortic dissection

研究者

发起方
SERAY TÜRKMEN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

SERAY TÜRKMEN

Associate Professor of Anesthesiology

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

研究点 (1)

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