Menu
Recruiting NCT07445997

The Association Between Preoperative HbA1c Levels and Postoperative Acute Kidney Injury in Isolated Coronary Artery Bypass Surgery

Observational Acute Kidney Injuries Hemoglobin A1c Protein, Human Coronary Bypass Graft Surgery Renal Resistive Index

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Kidney Injuries, Hemoglobin A1c Protein, Human, Coronary Bypass Graft Surgery, Renal Resistive Index. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

"The Association Between Preoperative HbA1c Levels and Postoperative Acute Kidney Injury in Isolated Coronary Artery Bypass Surgery: A Prospective Observational Study"

Overview

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.

Primary outcome measures

  • 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]
Secondary outcome measures (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 [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]

Eligibility criteria

Inclusion criteria

  • Patients undergoing isolated elective CABG surgery
  • Patients with available preoperative and postoperative Doppler RRI measurements
  • Patients with available HbA1c data

Exclusion criteria

  • 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%)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • University of Health Sciences, Bursa Yuksek Ihtisas Training & Research Hospital — Bursa

Identifiers

NCT: NCT07445997 · 2024-TBEK 2025/12-16

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗