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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury Cardiac Surgery

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 113

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34384
      • SBU Prof. Dr. Cemil Tascioglu City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Renal Regional Oxygen Saturation (rSO₂) and Its Association With Postoperative Acute Kidney Injury	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Between Renal and Cerebral rSO₂ Values	The correlation between renal and cerebral regional oxygen saturation (rSO₂, %) values measured using NIRS during intraoperative phases will be analyzed.	Intraoperative period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative EuroSCORE	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)	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)	Total cardiopulmonary bypass duration (minutes) will be recorded and analyzed in relation to postoperative AKI.	Intraoperative period
Duration of Surgery (hours)	Total surgical duration (hours) will be recorded and analyzed in relation to postoperative AKI.	Intraoperative period

Collaborators and Investigators

• Sponsor: SERAY TÜRKMEN

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Actual): February 1, 2026
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Near-Infrared Spectroscopy, Renal NIRS, Cardiopulmonary Bypass, Cardiac Surgery, Renal Oxygenation
• Other Study ID Numbers: Tascıoglu-RNIRS-KVC-2026; E-48670771-514.99-276161656 (Other Identifier: Ethics Committee, Istanbul Prof. Dr. Cemil Tascioglu City Hospital)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No