Association of Renal Oxygen Saturation and Neutrophil Gelatinase-Associated Lipocalin With Acute Kidney Injury After Cardiac Surgery With Cardiopulmonary Bypass: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Discriminatory Performance of Perioperative Renal Oxygen Saturation for Postoperative AKI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Adult patients undergoing elective cardiac surgery with CPB. Perioperative renal oxygen saturation and NGAL levels were evaluated, and patients were followed for postoperative AKI.
干预措施: Renal Near-Infrared Spectroscopy Monitoring (Diagnostic Test)
Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Adult patients undergoing elective cardiac surgery with CPB. Perioperative renal oxygen saturation and NGAL levels were evaluated, and patients were followed for postoperative AKI.
干预措施: Neutrophil Gelatinase-Associated Lipocalin (NGAL) Measurement (Diagnostic Test)
结局指标
主要结局
Discriminatory Performance of Perioperative Renal Oxygen Saturation for Postoperative AKI
时间窗: 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.
Discriminatory Performance of NGAL for Postoperative AKI
时间窗: 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.
Combined Discriminatory Performance of Renal Oxygen Saturation and NGAL for Postoperative AKI
时间窗: 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.
次要结局
- Incidence of Postoperative Acute Kidney Injury(Within 7 days after surgery.)
- Severity of Postoperative Acute Kidney Injury(Within 7 days after surgery.)
- Patient-Related and Perioperative Factors Associated With Postoperative AKI(From the preoperative period through postoperative day 7.)
研究者
Sinan Uzman
Head of ICU
Haseki Training and Research Hospital