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Идёт набор NCT07445997

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

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Acute Kidney Injuries, Hemoglobin A1c Protein, Human, Coronary Bypass Graft Surgery, Renal Resistive Index. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Первичные конечные точки

  • 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 [Срок оценки: 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]
Вторичные конечные точки (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 [Срок оценки: 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 [Срок оценки: Time Frame: From date of surgery until hospital discharge, up to 3 month]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

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

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗