Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Turkey (Türkiye)
Location contact
Nuri Burkay Soylu, MD
CONTACT
Nuri Burkay Soylu, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07821983
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Bursa, Turkey (Türkiye)
Nuri Burkay Soylu, MD
CONTACT
Nuri Burkay Soylu, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Renal Doppler Ultrasound
Time frame: 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.
Time frame: 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.
Time frame: During the index hospitalization, up to 30 days after surgery
Number and percentage of participants who require postoperative renal replacement therapy.
Time frame: 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.
Time frame: 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.
Time frame: During the index hospitalization, up to 30 days after surgery
Duration of the index hospital stay, measured in days from surgery to hospital discharge.
Time frame: 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.
Time frame: Through 30 days after surgery
Number and percentage of participants who die from any cause within 30 days after surgery.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Bursa Yuksek Ihtisas Training and Research Hospital
Other Gov
Role of Renal Augmented Velocity Index and Resistive Index in Predicting Postoperative Acute Kidney Injury After Isolated Coronary Artery Bypass Grafting
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View the official ClinicalTrials.gov record (opens in a new tab)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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