Role of Renal Augmented Velocity Index and Resistive Index in Predicting Postoperative Acute Kidney Injury After Isolated Coronary Artery Bypass Grafting
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of Acute Kidney Injury According to KDIGO Criteria
研究概览
简要总结
Acute kidney injury can occur after coronary artery bypass grafting (CABG). This prospective, single-center observational study will evaluate whether two measurements obtained from renal Doppler ultrasound-the renal augmented velocity index (AVI) and renal resistive index (RRI)-can help predict postoperative acute kidney injury. About 200 adults undergoing elective isolated CABG with cardiopulmonary bypass will have bilateral renal Doppler examinations one day before surgery, within 60 minutes after admission to the intensive care unit, and 6 hours after intensive care unit admission. The primary outcome is acute kidney injury within the first 7 days after surgery, defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Ultrasound measurements will be analyzed offline and will not influence clinical care.
详细描述
This is an academic, prospective observational cohort study at Bursa Yuksek Ihtisas Training and Research Hospital. Adults scheduled for elective isolated on-pump CABG who provide informed consent will be enrolled consecutively.
Bilateral renal Doppler waveforms will be obtained at three time points: T0, one day before surgery after at least 10 minutes of rest; T1, within the first 60 minutes after postoperative intensive care unit admission; and T2, 6 hours after intensive care unit admission. AVI and RRI will be calculated from stored waveforms by investigators blinded to clinical outcomes. No treatment decisions will be based on these study measurements. No additional blood or urine samples will be collected for research, and no biospecimens will be retained.
The primary analysis will assess the association and predictive performance of perioperative AVI and RRI measurements for KDIGO-defined acute kidney injury within 7 postoperative days. Secondary analyses will evaluate severe acute kidney injury, renal replacement therapy, mechanical ventilation duration, intensive care unit and hospital length of stay, major postoperative complications, 30-day mortality, renal function and renal recovery at day 30, and perioperative changes in AVI and RRI.
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 or older.
- •Scheduled for elective isolated coronary artery bypass grafting with cardiopulmonary bypass (on-pump).
- •Able and willing to provide written informed consent.
- •Both kidneys present.
- •Adequate bilateral preoperative renal Doppler signal for study measurements.
排除标准
- •Preoperative chronic dialysis or renal replacement therapy.
- •Urgent or emergency surgery.
- •Combined cardiac surgery, including valve, aortic, or another major additional procedure.
- •Off-pump coronary artery bypass grafting or conversion of the planned surgical technique.
- •Clinically significant rhythm disturbance preventing acquisition of three interpretable cardiac cycles.
- •Renal transplant, solitary kidney, significant renal artery stenosis, previous renal artery intervention, hydronephrosis, or other relevant renal vascular or structural disease.
- •Inadequate bilateral preoperative renal Doppler examination.
- •Withdrawal of consent.
研究组 & 干预措施
Elective Isolated On-Pump CABG Cohort
Adults scheduled for elective isolated coronary artery bypass grafting with cardiopulmonary bypass. Bilateral renal Doppler ultrasonography is performed one day before surgery and at 0 and 6 hours after ICU admission. Renal augmented velocity index and renal resistive index measurements are analyzed offline and are not used to guide clinical care.
干预措施: Renal Doppler Ultrasonography (Diagnostic Test)
结局指标
主要结局
Incidence of Acute Kidney Injury According to KDIGO Criteria
时间窗: From surgery through postoperative day 7
Number and percentage of participants who develop acute kidney injury according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria, based on serum creatinine and/or urine output.
次要结局
- Incidence of KDIGO Stage 2 or 3 Acute Kidney Injury(From surgery through postoperative day 7)
- Need for Renal Replacement Therapy(During the index hospitalization, up to 30 days after surgery)
- Duration of Mechanical Ventilation(During the index hospitalization, up to 30 days after surgery)
- Intensive Care Unit Length of Stay(During the index hospitalization, up to 30 days after surgery)
- Hospital Length of Stay(During the index hospitalization, up to 30 days after surgery)
- Incidence of Major Postoperative Complications(During the index hospitalization, up to 30 days after surgery)
- All-Cause Mortality(Through 30 days after surgery)
- Renal Function and Renal Recovery at Day 30(30 days after surgery)
- Change in Renal Doppler Indices(From one day before surgery through 6 hours after intensive care unit admission)
研究者
Nuri Burkay Soylu
Principal Investigator, Specialist Physician
Bursa Yuksek Ihtisas Training and Research Hospital