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Renal Near-Infrared Spectroscopy Monitoring and Postoperative Acute Kidney Injury in Cardiac Surgery (RENAL-CPB-NIRS)

2026年5月7日 更新者:SERAY TÜRKMEN

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

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.

研究概览

地位

完全的

详细说明

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.

All patients will receive standard anesthesia management and cardiopulmonary bypass procedures according to institutional protocols. Urine output, cardiopulmonary bypass duration, total operation time, intraoperative blood transfusion, use of diuretics, and ultrafiltration will also be recorded.

Postoperative renal function will be evaluated by measuring serum creatinine levels and urine output. Patients will be followed in the cardiovascular intensive care unit, and laboratory parameters including creatinine and estimated glomerular filtration rate will be recorded for seven days after surgery.

Acute kidney injury will be defined according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria. Patients will be classified into two groups according to the presence or absence of postoperative acute kidney injury, and the relationship between intraoperative renal NIRS measurements and the development of AKI will be analyzed.

研究类型

观察性的

注册 (实际的)

113

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Istanbul
      • Istanbul、Istanbul、土耳其(türkiye)、34384
        • SBU Prof. Dr. Cemil Tascioglu City Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass, including coronary artery bypass grafting and/or heart valve surgery, with preserved preoperative renal function and meeting all inclusion and exclusion criteria.

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass will be prospectively observed. Renal and cerebral tissue oxygen saturation will be monitored intraoperatively using near-infrared spectroscopy (NIRS). Hemodynamic parameters, intraoperative variables, and laboratory results will be recorded. Patients will be followed postoperatively for the development of acute kidney injury according to KDIGO criteria.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Intraoperative Renal Regional Oxygen Saturation (rSO₂) and Its Association With Postoperative Acute Kidney Injury
大体时间:Intraoperative period (from induction to end of surgery) and within 7 days after surgery
Renal regional oxygen saturation (rSO₂, %) values measured using near-infrared spectroscopy (NIRS) will be recorded at predefined intraoperative time points: pre-induction (baseline), post-induction, during cardiopulmonary bypass (CPB), and post-CPB. A total of seven measurements will be obtained. Mean values, minimum values, and duration (minutes) spent at minimum levels will be analyzed in relation to the development of postoperative acute kidney injury (AKI), defined according to KDIGO criteria based on serum creatinine levels and urine output.
Intraoperative period (from induction to end of surgery) and within 7 days after surgery

次要结果测量

结果测量
措施说明
大体时间
Correlation Between Renal and Cerebral rSO₂ Values
大体时间:Intraoperative period
The correlation between renal and cerebral regional oxygen saturation (rSO₂, %) values measured using NIRS during intraoperative phases will be analyzed.
Intraoperative period

其他结果措施

结果测量
措施说明
大体时间
Preoperative EuroSCORE
大体时间:Preoperative assessment]
Preoperative EuroSCORE values calculated for the planned cardiac surgical procedure will be recorded and analyzed in relation to postoperative AKI.
Preoperative assessment]
ICU Length of Stay (days)
大体时间:Patients were followed from ICU admission until postoperative day 28. The maximum observed ICU length of stay in the study population was 21 days.]
Length of stay in the intensive care unit (days) will be recorded and compared between patients with and without postoperative AKI.
Patients were followed from ICU admission until postoperative day 28. The maximum observed ICU length of stay in the study population was 21 days.]
Duration of Cardiopulmonary Bypass (minutes)
大体时间:Intraoperative period
Total cardiopulmonary bypass duration (minutes) will be recorded and analyzed in relation to postoperative AKI.
Intraoperative period
Duration of Surgery (hours)
大体时间:Intraoperative period
Total surgical duration (hours) will be recorded and analyzed in relation to postoperative AKI.
Intraoperative period

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年5月12日

初级完成 (实际的)

2026年2月1日

研究完成 (实际的)

2026年2月1日

研究注册日期

首次提交

2026年4月27日

首先提交符合 QC 标准的

2026年5月7日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年5月12日

上次提交的符合 QC 标准的更新

2026年5月7日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • Tascıoglu-RNIRS-KVC-2026
  • E-48670771-514.99-276161656 (其他标识符:Ethics Committee, Istanbul Prof. Dr. Cemil Tascioglu City Hospital)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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