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NCT Number: NCT07837037

Kidney Oxygen Saturation and NGAL for Detecting Acute Kidney Injury After Cardiac Surgery

Acute kidney injury (AKI) is an important complication following cardiac surgery with cardiopulmonary bypass (CPB). Early identification of patients at risk of AKI may facilitate timely clinical management.

This prospective observational study investigated the association of perioperative renal regional oxygen saturation (rSO₂), measured using near-infrared spectroscopy (NIRS), and neutrophil gelatinase-associated lipocalin (NGAL) levels with postoperative AKI.

A total of 85 adult patients undergoing elective cardiac surgery with CPB were enrolled. Bilateral renal rSO₂ was measured during four predefined perioperative phases. NGAL levels were evaluated preoperatively and at 24 and 48 hours postoperatively.

The primary objective was to assess the discriminatory performance of renal rSO₂ and NGAL, individually and in combination, for identifying postoperative AKI.

AKI was defined and staged according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria during the first seven postoperative days. Secondary objectives included determining the incidence and severity of AKI and investigating associated patient-related and perioperative factors.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sultangazi Haseki Training and Research Hospital

Istanbul, 34265, Turkey (Türkiye)

About this study

This prospective, single-center observational study was conducted at Haseki Training and Research Hospital, Istanbul, Türkiye, between March 20, 2025, and February 20, 2026. The study received ethics committee approval on March 19, 2025 (approval number: 34-2025), and written informed consent was obtained from all participants.

Among 95 adult patients assessed for eligibility, 85 patients undergoing elective cardiac surgery with cardiopulmonary bypass (CPB) were enrolled.

Renal regional oxygen saturation (rSO₂) was monitored using bilateral near-infrared spectroscopy (NIRS) probes placed over the renal regions. Perioperative measurements were collected during four predefined phases:

A0: Before induction of anesthesia.

A1: From induction of anesthesia to initiation of CPB.

A2: From initiation of CPB to separation from CPB.

A3: From separation from CPB to the end of surgery.

During A1, A2, and A3, right and left renal rSO₂ values and other perioperative parameters were recorded every 15 minutes. Mean values were calculated separately for each phase. Bilateral mean renal rSO₂ was calculated as the arithmetic mean of the corresponding right- and left-sided values and was used as the primary renal oxygenation parameter.

Urine output was recorded for each perioperative phase and expressed as mL/kg/h.

NGAL levels were measured preoperatively (T0) and at 24 (T24) and 48 (T48) hours postoperatively.

Postoperative AKI was assessed during the first seven postoperative days according to KDIGO criteria using serum creatinine changes and/or urine output.

Participants were classified into AKI and non-AKI groups according to postoperative AKI development.

The diagnostic performance of renal rSO₂ and NGAL was assessed using receiver operating characteristic (ROC) curve analysis. The primary combined biomarker model incorporated bilateral mean renal rSO₂ during CPB (A2) and NGAL measured at 24 hours postoperatively (T24).

Additional analyses investigated temporal changes in biomarkers and potential patient-related and perioperative factors associated with postoperative AKI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years.
  • Scheduled for elective cardiac surgery with cardiopulmonary bypass.
  • Expected postoperative coronary intensive care unit stay of at least 48 hours.
  • Written informed consent provided.

Exclusion criteria

  • Previously diagnosed renal disease, including acute tubular necrosis, chronic kidney disease, or nephropathy.
  • Use of medications known to affect renal function, including nonsteroidal anti-inflammatory drugs (NSAIDs).
  • History of renal surgery or kidney transplantation.
  • Skin-to-kidney depth ≥4 cm.
  • Emergency cardiac surgery.
  • Off-pump cardiac surgery.
  • Preoperative estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m².
  • Intraoperative conditions requiring a reduction in cardiopulmonary bypass pump flow with mean arterial pressure below 50 mmHg.

Treatment and study plan

Renal Near-Infrared Spectroscopy Monitoring

Diagnostic Test

Bilateral renal regional oxygen saturation (rSO₂) was monitored using near-infrared spectroscopy (NIRS). Measurements were obtained before anesthesia induction (A0) and recorded at 15-minute intervals during three perioperative phases (A1, A2, and A3). The mean rSO₂ values were calculated separately for each kidney, and the bilateral mean was used as the primary renal oxygenation parameter.

Neutrophil Gelatinase-Associated Lipocalin (NGAL) Measurement

Diagnostic Test

Blood samples were collected to measure neutrophil gelatinase-associated lipocalin (NGAL) levels at three predefined time points: preoperatively (T0), and at 24 (T24) and 48 (T48) hours postoperatively. NGAL levels were evaluated for their association with postoperative acute kidney injury.

Primary outcomes

  1. Discriminatory Performance of Perioperative Renal Oxygen Saturation for Postoperative AKI

    Time frame: Perioperatively (A0-A3), with postoperative AKI assessed through day 7.

    The discriminatory performance of bilateral mean renal rSO₂ for identifying postoperative AKI will be evaluated separately for each perioperative phase (A0, A1, A2, and A3) using ROC curve analysis. The area under the curve (AUC) and its 95% confidence interval will be calculated.

  2. Discriminatory Performance of NGAL for Postoperative AKI

    Time frame: Preoperatively and at 24 and 48 hours postoperatively, with AKI assessed through postoperative day 7.

    The discriminatory performance of NGAL levels measured preoperatively (T0), at 24 hours (T24), and at 48 hours (T48) postoperatively will be evaluated separately using ROC curve analysis. AUC values and corresponding 95% confidence intervals will be calculated.

  3. Combined Discriminatory Performance of Renal Oxygen Saturation and NGAL for Postoperative AKI

    Time frame: During CPB and at 24 hours postoperatively, with AKI assessed through postoperative day 7.

    The primary combined biomarker model will incorporate bilateral mean renal rSO₂ during CPB (A2) and NGAL measured at 24 hours postoperatively (T24). Binary logistic regression will be used to derive predicted probabilities, and ROC analysis will be performed to calculate the AUC and its 95% confidence interval. Incremental discrimination will be assessed by comparing AUCs with those of the individual biomarker models.

Secondary outcomes

  1. Incidence of Postoperative Acute Kidney Injury

    Time frame: Within 7 days after surgery.

    The proportion of patients developing postoperative AKI, defined according to KDIGO criteria using serum creatinine changes and/or urine output.

  2. Severity of Postoperative Acute Kidney Injury

    Time frame: Within 7 days after surgery.

    Postoperative AKI severity will be classified according to KDIGO stages 1, 2, and 3, based on serum creatinine changes and/or urine output.

  3. Patient-Related and Perioperative Factors Associated With Postoperative AKI

    Time frame: From the preoperative period through postoperative day 7.

    Associations of demographic characteristics, comorbidities, preoperative renal function, CPB duration, aortic cross-clamp duration, and relevant intraoperative clinical and hemodynamic variables with postoperative AKI will be evaluated using logistic regression. Odds ratios and 95% confidence intervals will be reported.

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

Association of Renal Oxygen Saturation and Neutrophil Gelatinase-Associated Lipocalin With Acute Kidney Injury After Cardiac Surgery With Cardiopulmonary Bypass: A Prospective Observational Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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