Acute Kidney Injury, Coronary Artery Disease
Conditions
Keywords
renal augmented velocity index, renal resistive index, renal Doppler ultrasonography, acute kidney injury, coronary artery bypass grafting, cardiac surgery, KDIGO, prognostic biomarker
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTRenal Doppler Ultrasonography
Bilateral renal Doppler examinations are performed at T0 (one day before surgery after at least 10 minutes of rest), T1 (within the first 60 minutes after postoperative ICU admission), and T2 (6 hours after ICU admission). Renal augmented velocity index and renal resistive index are calculated offline from stored waveforms. Study measurements do not guide clinical care.
Sponsors
Bursa Yuksek Ihtisas Training and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Acute Kidney Injury According to KDIGO Criteria | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of KDIGO Stage 2 or 3 Acute Kidney Injury | From surgery through postoperative day 7 | Number and percentage of participants who develop KDIGO stage 2 or 3 acute kidney injury based on serum creatinine and/or urine output criteria. |
| Need for Renal Replacement Therapy | During the index hospitalization, up to 30 days after surgery | Number and percentage of participants who require postoperative renal replacement therapy. |
| Duration of Mechanical Ventilation | During the index hospitalization, up to 30 days after surgery | Duration of invasive mechanical ventilation, measured in hours from postoperative intensive care unit admission until successful extubation. |
| Intensive Care Unit Length of Stay | During the index hospitalization, up to 30 days after surgery | Duration of postoperative intensive care unit stay, measured in days from intensive care unit admission to intensive care unit discharge. |
| Hospital Length of Stay | During the index hospitalization, up to 30 days after surgery | Duration of the index hospital stay, measured in days from surgery to hospital discharge. |
| Incidence of Major Postoperative Complications | During the index hospitalization, up to 30 days after surgery | Number and percentage of participants with one or more major postoperative complications, including low cardiac output syndrome, perioperative myocardial infarction, new atrial fibrillation or serious arrhythmia, stroke or transient ischemic attack, reoperation for bleeding, sepsis or serious infection, prolonged vasopressor requirement, or mechanical circulatory support. |
| All-Cause Mortality | Through 30 days after surgery | Number and percentage of participants who die from any cause within 30 days after surgery. |
| Renal Function and Renal Recovery at Day 30 | 30 days after surgery | Serum creatinine and estimated glomerular filtration rate at day 30 will be compared with preoperative baseline values to assess renal recovery. |
| Change in Renal Doppler Indices | From one day before surgery through 6 hours after intensive care unit admission | Change in renal augmented velocity index and renal resistive index from the preoperative T0 measurement to T1 and T2 postoperative measurements. |
Countries
Turkey (Türkiye)
Contacts
CONTACTNuri Burkay Soylu, MD
PRINCIPAL_INVESTIGATORNuri Burkay Soylu, MD
Bursa Yuksek Ihtisas Training and Research Hospital
Outcome results
None listed