Renal Near-Infrared Spectroscopy Monitoring and Postoperative Acute Kidney Injury in Cardiac Surgery

NCT07582393 | Completed

• 2 other identifiers: Tascıoglu-RNIRS-KVC-2026E-48670771-514.99-276161656
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Kidney Injury Cardiac Surgery

Keywords

Near-Infrared Spectroscopy, Renal NIRS, Cardiopulmonary Bypass, Cardiac Surgery, Renal Oxygenation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation Between Renal and Cerebral rSO₂ Values

  Intraoperative period

Other Outcomes (4)

• Preoperative EuroSCORE

  Preoperative assessment]

• ICU Length of Stay (days)

  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)

  Intraoperative period

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SERAY TÜRKMEN: lead

Study Sites (1)

SBU Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, Istanbul, 34384, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 12, 2026
• Study Start: May 12, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-04

Locations

TU (1)