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Acute Kidney Injury Cardiac SurgeryRENAL-CPB-NIRSNCT07582393

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

An observational study of Acute Kidney Injury Cardiac Surgery, run by SERAY TÜRKMEN at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Kidney Injury Cardiac Surgery
How many people
113 participants
Where
1 siteTurkey (Türkiye)
Study dates
12 May 2025to 1 Feb 2026
How long will I take part?
7 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Preoperative mechanical ventilation
  • STEMI or NSTEMI requiring contrast administration
  • Planned total circulatory arrest
  • Acute aortic dissection

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • SBU Prof. Dr. Cemil Tascioglu City Hospital

    Istanbul, Istanbul, 34384

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Read the 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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07582393
Study groupRoleWhat they receive
Patients Undergoing Cardiac Surgery With Cardiopulmonary BypassAdult 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Intraoperative period (from induction to end of surgery) and within 7 days after surgery

Secondary outcomes (1)
  1. 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.

    Measured: Intraoperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2026
  2. Study start12 May 2025
  3. Primary completion1 Feb 2026
  4. Study completion1 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
113 participants (actual)
Target duration
7 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07582393
Sponsor's protocol ID
Tascıoglu-RNIRS-KVC-2026
Other IDs
E-48670771-514.99-276161656
Acronym
RENAL-CPB-NIRS
Status last verified
Apr 2026
First submitted
27 Apr 2026
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Kidney Injury Cardiac Surgery, run by SERAY TÜRKMEN at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative Renal Regional Oxygen Saturation (rSO₂) and Its Association With Postoperative Acute Kidney Injury (time frame: Intraoperative period (from induction to end of surgery) and within 7 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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