- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07821983
Renal Doppler Indices for Predicting Acute Kidney Injury After Isolated CABG
Role of Renal Augmented Velocity Index and Resistive Index in Predicting Postoperative Acute Kidney Injury After Isolated Coronary Artery Bypass Grafting
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nuri Burkay Soylu, MD
- Phone Number: +90 538 248 4728
- Email: drburkaysoylu@gmail.com
Study Locations
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Bursa
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Bursa, Bursa, Turkey (Türkiye)
- Bursa Yuksek Ihtisas Training and Research Hospital
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Contact:
- Nuri Burkay Soylu, MD
- Phone Number: +90 538 248 4728
- Email: drburkaysoylu@gmail.com
-
Principal Investigator:
- Nuri Burkay Soylu, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of Acute Kidney Injury According to KDIGO Criteria
Time Frame: From surgery through postoperative day 7
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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.
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From surgery through postoperative day 7
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of KDIGO Stage 2 or 3 Acute Kidney Injury
Time Frame: From surgery through postoperative day 7
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Number and percentage of participants who develop KDIGO stage 2 or 3 acute kidney injury based on serum creatinine and/or urine output criteria.
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From surgery through postoperative day 7
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Need for Renal Replacement Therapy
Time Frame: During the index hospitalization, up to 30 days after surgery
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Number and percentage of participants who require postoperative renal replacement therapy.
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During the index hospitalization, up to 30 days after surgery
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Duration of Mechanical Ventilation
Time Frame: During the index hospitalization, up to 30 days after surgery
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Duration of invasive mechanical ventilation, measured in hours from postoperative intensive care unit admission until successful extubation.
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During the index hospitalization, up to 30 days after surgery
|
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Intensive Care Unit Length of Stay
Time Frame: During the index hospitalization, up to 30 days after surgery
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Duration of postoperative intensive care unit stay, measured in days from intensive care unit admission to intensive care unit discharge.
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During the index hospitalization, up to 30 days after surgery
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Hospital Length of Stay
Time Frame: During the index hospitalization, up to 30 days after surgery
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Duration of the index hospital stay, measured in days from surgery to hospital discharge.
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During the index hospitalization, up to 30 days after surgery
|
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Incidence of Major Postoperative Complications
Time Frame: During the index hospitalization, up to 30 days after surgery
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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.
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During the index hospitalization, up to 30 days after surgery
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All-Cause Mortality
Time Frame: Through 30 days after surgery
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Number and percentage of participants who die from any cause within 30 days after surgery.
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Through 30 days after surgery
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Renal Function and Renal Recovery at Day 30
Time Frame: 30 days after surgery
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Serum creatinine and estimated glomerular filtration rate at day 30 will be compared with preoperative baseline values to assess renal recovery.
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30 days after surgery
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Change in Renal Doppler Indices
Time Frame: From one day before surgery through 6 hours after intensive care unit admission
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Change in renal augmented velocity index and renal resistive index from the preoperative T0 measurement to T1 and T2 postoperative measurements.
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From one day before surgery through 6 hours after intensive care unit admission
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Collaborators and Investigators
Investigators
- Principal Investigator: Nuri Burkay Soylu, MD, Bursa Yuksek Ihtisas Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Heart Diseases
- Renal Insufficiency
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Myocardial Ischemia
- Acute Kidney Injury
- Coronary Artery Disease
Other Study ID Numbers
- 2024-TBEK 2026/09-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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