Renal Doppler Indices for Predicting Acute Kidney Injury After Isolated CABG
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBursa Yuksek Ihtisas Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adults scheduled for elective isolated on-pump coronary artery bypass grafting at Bursa Yuksek Ihtisas Training and Research Hospital who meet all eligibility criteria. Consecutive eligible patients will be approached before surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Renal Doppler Ultrasonography
Diagnostic testBilateral 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Elective Isolated On-Pump CABG Cohort1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Acute Kidney Injury According to KDIGO Criteria
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 7Secondary outcomes
1
Incidence of KDIGO Stage 2 or 3 Acute Kidney Injury
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
From surgery through postoperative day 72
Need for Renal Replacement Therapy
Number and percentage of participants who require postoperative renal replacement therapy.
Time frame
During the index hospitalization, up to 30 days after surgery3
Duration of Mechanical Ventilation
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 surgery4
Intensive Care Unit Length of Stay
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 surgerySponsors and contacts
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Source ClinicalTrials.gov
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