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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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (実際)

113

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Istanbul
      • Istanbul、Istanbul、トルコ(Türkiye)、34384
        • SBU Prof. Dr. Cemil Tascioglu City Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Intraoperative Renal Regional Oxygen Saturation (rSO₂) and Its Association With Postoperative Acute Kidney Injury
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Correlation Between Renal and Cerebral rSO₂ Values
時間枠:Intraoperative period
The correlation between renal and cerebral regional oxygen saturation (rSO₂, %) values measured using NIRS during intraoperative phases will be analyzed.
Intraoperative period

その他の成果指標

結果測定
メジャーの説明
時間枠
Preoperative EuroSCORE
時間枠: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)
時間枠: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)
時間枠:Intraoperative period
Total cardiopulmonary bypass duration (minutes) will be recorded and analyzed in relation to postoperative AKI.
Intraoperative period
Duration of Surgery (hours)
時間枠:Intraoperative period
Total surgical duration (hours) will be recorded and analyzed in relation to postoperative AKI.
Intraoperative period

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年5月12日

一次修了 (実際)

2026年2月1日

研究の完了 (実際)

2026年2月1日

試験登録日

最初に提出

2026年4月27日

QC基準を満たした最初の提出物

2026年5月7日

最初の投稿 (実際)

2026年5月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月12日

QC基準を満たした最後の更新が送信されました

2026年5月7日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Tascıoglu-RNIRS-KVC-2026
  • E-48670771-514.99-276161656 (その他の識別子:Ethics Committee, Istanbul Prof. Dr. Cemil Tascioglu City Hospital)

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