Acute Kidney InjuriesNCT07445997
The Association Between Preoperative HbA1c Levels and Postoperative Acute Kidney Injury in Isolated Coronary Artery Bypass Surgery
An observational study of Acute Kidney Injuries and Hemoglobin A1c Protein, Human, run by Osman Sila Aydin at 1 site in Turkey (Türkiye).
Trial summary
Renal complications are frequently encountered in cardiac surgery and constitute significant causes of morbidity and mortality. They most commonly present in the form of acute kidney injury (AKI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injuries, Hemoglobin A1c Protein, Human, Coronary Bypass Graft Surgery
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2026to 30 Aug 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: isolated coronary bypass graft surgery patients
Who may be able to join
- Patients undergoing isolated elective CABG surgery
- Patients with available preoperative and postoperative Doppler RRI measurements
- Patients with available HbA1c data
Who cannot join
- Patients with chronic kidney disease
- Emergency surgeries
- Redo/revision surgeries
- Patients undergoing concomitant valve surgery
- Presence of acute infection or sepsis
- Advanced heart failure (EF <30%)
Show all 11Show fewer
- Requirement for intra-aortic balloon pump, pacemaker, or mechanical circulatory support
- History of nephrectomy or single kidney
- Preoperative serum creatinine >2.0 mg/dL
- Pregnancy
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences, Bursa Yuksek Ihtisas Training & Research Hospital
Bursa
Osman Sıla AYDIN, +(90)5059661014, osmansila@gmail.com
About this study
Official title: "The Association Between Preoperative HbA1c Levels and Postoperative Acute Kidney Injury in Isolated Coronary Artery Bypass Surgery: A Prospective Observational Study"
Renal complications are frequently encountered in cardiac surgery and constitute significant causes of morbidity and mortality. They most commonly present in the form of acute kidney injury (AKI). The etiological factors of AKI include hemodynamic alterations, hemolysis and pigment nephropathy, inflammatory response and cytokine storm, ischemia-reperfusion injury, use of nephrotoxic agents, patient-related risk factors (advanced age, diabetes mellitus, preoperative renal insufficiency, congestive heart failure, hypertension, anemia), duration of surgery, and postoperative complications such as low cardiac output syndrome, sepsis, bleeding and reoperation, hypoalbuminemia, and fluid imbalance.
Previous studies have demonstrated several mechanisms through which elevated HbA1c levels may contribute to acute renal injury, including glomerular damage and hyperfiltration, endothelial dysfunction and microvascular injury, tubular damage, accumulation of glycation products and advanced glycation end products (AGEs), structural changes in blood vessels, and metabolic and systemic factors.
Read more
The evaluation of acute renal failure relies on fundamental scoring systems, biomarkers, and imaging modalities. Among the scoring systems, the most current and widely used is the KDIGO (Kidney Disease: Improving Global Outcomes) classification. According to the KDIGO definition, the diagnosis of AKI can be established when at least one of the following three criteria is met: an increase in serum creatinine of ≥0.3 mg/dL within 48 hours, an increase in serum creatinine to ≥1.5 times baseline within 7 days, or a urine output of <0.5 mL/kg/hour for more than 6 hours. AKI staging is performed based on these parameters.
Imaging modalities used in the assessment of renal function include renal ultrasonography (US), Doppler ultrasonography with measurement of the renal resistive index (RRI), renal MRI/MR angiography, and renal computed tomography (particularly CT angiography). RRI is a non-invasive, bedside-applicable method that provides direct information about renal vascular resistance by evaluating renal arterial flow patterns.
In our clinic, the rationale of the present study is to measure preoperative HbA1c and Doppler-derived RRI values in patients undergoing isolated coronary artery bypass surgery, and to evaluate their relationship with postoperative KDIGO classification and Doppler RRI values in order to gain insight into the development of AKI.
- Conditions
- Acute Kidney Injuries, Hemoglobin A1c Protein, Human, Coronary Bypass Graft Surgery, Renal Resistive Index
- Keywords
- acute kidney injuries, hemoglobin A1c protein, coronary bypass graft surgery, renal resistive index
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| isolated coronary bypass graft surgery patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the correlation between preoperative HbA1c Level, Doppler-Derived Renal Resistive Index (RRI), and development of acute kidney injury (KDIGO Criteria) after isolated coronary artery bypass grafting
Preoperative HbA1c Level; Glycated hemoglobin level will be measured from blood samples preoperatively.
Unit of Measure: Percentage (%) Measurement Tool:Standard laboratory high-performance liquid chromatography (HPLC) assay Preoperative and Postoperative Renal Resistive Index(RRI) RRI will be measured using Doppler ultrasonography from segmental or interlobar renal arteries.
Unit of Measure: Dimensionless ratio (RRI value) Measurement Tool: Doppler ultrasonography Normal Value Reference: RRI < 0.70 Outcome Measure Title: Incidence of Acute Kidney Injury (KDIGO Criteria) Acute kidney injury will be assessed according to KDIGO criteria. Unit of Measure: Incidence of AKI (% of patients meeting KDIGO criteria) AKI Stage (Stage 1-3 classification) Measurement Tool: Serum creatinine measurement (mg/dL) Urine output monitoring Definition: Increase in serum creatinine ≥0.3 mg/dL within 48 hours OR increase to ≥1.5 times baseline within 7 days OR urine output <0.5 mL/kg/hour for ≥6 hours
Measured: Preoperative HbA1c Level Time Frame: Within 7 days prior to surgery Preoperative and Postoperative Renal Resistive Index (RRI) within 24 hours preoperatively and within 24 hours postoperatively KDIGO : 48 hours postoperatively,7 days postoperatively
Secondary outcomes (2)
To evaluate the correlation between preoperative HbA1c Level, Doppler-Derived Renal Resistive Index (RRI), and intensive care unit length of stay after isolated coronary artery bypass grafting
Length of Stay in the Intensive Care Unit Description:Duration of postoperative stay in the intensive care unit. Unit of Measure: Days Measurement Tool: Hospital electronic medical records
Measured: Time Frame: From ICU admission after surgery until ICU discharge, up to one month
To evaluate the correlation between preoperative HbA1c Level, Doppler-Derived Renal Resistive Index (RRI), and hospital length of stay after isolated coronary artery bypass grafting
Total Hospital Length of Stay Description: Total duration of hospitalization following surgery. Unit of Measure: Days Measurement Tool: Hospital electronic medical records
Measured: Time Frame: From date of surgery until hospital discharge, up to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start20 Jan 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Osman Sila Aydin
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Osman Sila Aydin, Bursa Sevket Yilmaz Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445997
- Sponsor's protocol ID
- 2024-TBEK 2025/12-16
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Association Between Preoperative HbA1c Levels and Postoperative Acute Kidney Injury in Isolated Coronary Artery Bypass Surgery: A Prospective Observational Study"
- ClinicalTrials.gov ID
- NCT07445997
- Acronym / sponsor ID
- 2024-TBEK 2025/12-16
- Conditions
- Acute Kidney Injuries, Hemoglobin A1c Protein, Human, Coronary Bypass Graft Surgery, Renal Resistive Index
- Keywords
- acute kidney injuries, hemoglobin A1c protein, coronary bypass graft surgery, renal resistive index
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Osman Sila AydinOther government
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Renal complications are frequently encountered in cardiac surgery and constitute significant causes of morbidity and mortality. They most commonly present in the form of acute kidney injury (AKI). The etiological factors of AKI include hemodynamic alterations, hemolysis and pigment nephropathy, inflammatory response and cytokine storm, ischemia-reperfusion injury, use of nephrotoxic agents, patient-related risk factors (advanced age, diabetes mellitus, preoperative renal insufficiency, congestive heart failure, hypertension, anemia), duration of surgery, and postoperative complications such as low cardiac output syndrome, sepsis, bleeding and reoperation, hypoalbuminemia, and fluid imbalance.
Previous studies have demonstrated several mechanisms through which elevated HbA1c levels may contribute to acute renal injury, including glomerular damage and hyperfiltration, endothelial dysfunction and microvascular injury, tubular damage, accumulation of glycation products and advanced glycation end products (AGEs), structural changes in blood vessels, and metabolic and systemic factors.
The evaluation of acute renal failure relies on fundamental scoring systems, biomarkers, and imaging modalities. Among the scoring systems, the most current and widely used is the KDIGO (Kidney Disease: Improving Global Outcomes) classification. According to the KDIGO definition, the diagnosis of AKI can be established when at least one of the following three criteria is met: an increase in serum creatinine of ≥0.3 mg/dL within 48 hours, an increase in serum creatinine to ≥1.5 times baseline within 7 days, or a urine output of <0.5 mL/kg/hour for more than 6 hours. AKI staging is performed based on these parameters.
Imaging modalities used in the assessment of renal function include renal ultrasonography (US), Doppler ultrasonography with measurement of the renal resistive index (RRI), renal MRI/MR angiography, and renal computed tomography (particularly CT angiography). RRI is a non-invasive, bedside-applicable method that provides direct information about renal vascular resistance by evaluating renal arterial flow patterns.
In our clinic, the rationale of the present study is to measure preoperative HbA1c and Doppler-derived RRI values in patients undergoing isolated coronary artery bypass surgery, and to evaluate their relationship with postoperative KDIGO classification and Doppler RRI values in order to gain insight into the development of AKI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| isolated coronary bypass graft surgery patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- isolated coronary bypass graft surgery patients
Key inclusion criteria (3 listed)
- Patients undergoing isolated elective CABG surgery
- Patients with available preoperative and postoperative Doppler RRI measurements
- Patients with available HbA1c data
Key exclusion criteria (11 listed)
- Patients with chronic kidney disease
- Emergency surgeries
- Redo/revision surgeries
- Patients undergoing concomitant valve surgery
- Presence of acute infection or sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the correlation between preoperative HbA1c Level, Doppler-Derived Renal Resistive Index (RRI), and development of acute kidney injury (KDIGO Criteria) after isolated coronary artery bypass grafting
Time frame: Preoperative HbA1c Level Time Frame: Within 7 days prior to surgery Preoperative and Postoperative Renal Resistive Index (RRI) within 24 hours preoperatively and within 24 hours postoperatively KDIGO : 48 hours postoperatively,7 days postoperatively
Preoperative HbA1c Level; Glycated hemoglobin level will be measured from blood samples preoperatively. Unit of Measure: Percentage (%) Measurement Tool:Standard laboratory high-performance liquid chromatography (HPLC) assay Preoperative and Postoperative Renal Resistive Index(RRI) RRI will be measured using Doppler ultrasonography from segmental or interlobar renal arteries. Unit of Measure: Dimensionless ratio (RRI value) Measurement Tool: Doppler ultrasonography Normal Value Reference: RRI < 0.70 Outcome Measure Title: Incidence of Acute Kidney Injury (KDIGO Criteria) Acute kidney injury will be assessed according to KDIGO criteria. Unit of Measure: Incidence of AKI (% of patients meeting KDIGO criteria) AKI Stage (Stage 1-3 classification) Measurement Tool: Serum creatinine measurement (mg/dL) Urine output monitoring Definition: Increase in serum creatinine ≥0.3 mg/dL within 48 hours OR increase to ≥1.5 times baseline within 7 days OR urine output <0.5 mL/kg/hour for ≥6 hours
2 secondary outcomes
To evaluate the correlation between preoperative HbA1c Level, Doppler-Derived Renal Resistive Index (RRI), and intensive care unit length of stay after isolated coronary artery bypass grafting
Time frame: Time Frame: From ICU admission after surgery until ICU discharge, up to one month
To evaluate the correlation between preoperative HbA1c Level, Doppler-Derived Renal Resistive Index (RRI), and hospital length of stay after isolated coronary artery bypass grafting
Time frame: Time Frame: From date of surgery until hospital discharge, up to 3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injuries and Hemoglobin A1c Protein, Human, run by Osman Sila Aydin at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact OSMAN SILA AYDIN (+(90)5059661014, osmansila@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the correlation between preoperative HbA1c Level, Doppler-Derived Renal Resistive Index (RRI), and development of acute kidney injury (KDIGO Criteria) after isolated coronary artery bypass grafting (time frame: Preoperative HbA1c Level Time Frame: Within 7 days prior to surgery Preoperative and Postoperative Renal Resistive Index (RRI) within 24 hours preoperatively and within 24 hours postoperatively KDIGO : 48 hours postoperatively,7 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.