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临床试验/NCT07803328
NCT07803328尚未招募不适用

Perioperative Role Of Vascular Endothelial Growth Factor In Cardiac Surgery-associated Acute Kidney Injury

Universität Münster1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
220
试验地点
1
主要终点
Association of vascular endothelial growth factor (VEGF) levels with postoperative acute kidney injury

研究概览

简要总结

The goal of this prospective observational study is to find out whether the protein vascular endothelial growth factor (VEGF) measured in blood and urine can predict which patients will develop acute kidney injury (AKI) after heart-type surgery that uses a heart-lung machine (cardiopulmonary bypass).

详细描述

Cardiac surgery-associated acute kidney injury (CSA-AKI) remains a common and serious complication affecting 20-30% of patients undergoing cardiac surgery, with significant implications for short- and long-term morbidity and mortality. The pathophysiology of CSA-AKI is multifactorial and incompletely understood. It involves hypoperfusion, ischemia-reperfusion injury, inflammation, and oxidative stress. Emerging evidence suggests that vascular endothelial dysfunction and microvascular injury play central roles in the development and progression of CSA-AKI. Vascular endothelial growth factor (VEGF) is a key regulator of endothelial cell survival, vascular permeability, inflammation, and angiogenesis. VEGF appears to play a critical role in maintaining renal microvascular homeostasis. While renal VEGF expression in vitro is induced by hypoxia, its renal expression and protein plasma levels have been shown to drop significantly following ischemia-reperfusion injury in a mouse model. These observations have been supported by an observational study that found an approximately 2-fold decrease in plasma concentrations of VEGF by 6 hours in patients that had underwent cardiac surgery with cardiopulmonary bypass (CPB). Conversely, higher early postoperative VEGF plasma concentrations have been independently associated with significantly reduced risk of AKI, shorter AKI duration and improved survival, suggesting a protective role for VEGF in the acute phase of CSA-AKI. However, while VEGF appears to be nephroprotective in the acute phase after cardiac surgery, it potentially contributes to chronic kidney disease (CKD) progression due to fibrosis and is associated with higher risk for progression to end stage kidney disease in patients with diabetic nephropathy. Despite these insights, the reliance of the only clinical study by Mansour et al. on plasma VEGF measurements may limit the precision with which renal VEGF dynamics can be characterized. Plasma VEGF reflects contributions from multiple non-renal sources, including platelets, leukocytes, vascular endothelium, and other tissues, all of which are substantially perturbed in the context of cardiac surgery. The resulting hemodilution, platelet activation and systemic inflammatory response inherent to extracorporeal circulation represent important confounders of circulating VEGF levels that are unrelated to renal pathophysiology. Consequently, the observed 2-fold decrease in plasma VEGF following cardiac surgery³ likely represents an attenuated and partially masked signal of what preclinical data suggest to be a far more pronounced local renal VEGF suppression. In contrast, urinary VEGF may provide a more specific representation of intrarenal VEGF (predominantly produced by glomerular podocytes) that is less susceptible to systemic confounders. Given the magnitude of renal VEGF suppression documented in the IRI model, urinary VEGF concentrations would be expected to demonstrate a substantially larger and more consistent signal in patients developing CSA-AKI compared to plasma-based measurements. The precise role of VEGF in the pathophysiology of CSA-AKI thus remains unclear. To date, urinary VEGF has not been systematically evaluated as a biomarker in the context of CSA-AKI, and direct comparative data with plasma VEGF in this setting are lacking. The temporal changes of VEGF expression, its relationship to specific injury mechanisms such as ischemia-reperfusion injury, oxidative stress, and inflammation and its potential utility as a predictive biomarker in the plasma/urine or therapeutic target require further investigation. The objective of this study is to comprehensively evaluate the role of VEGF in CSA-AKI by examining its urine and plasma concentration over time in relation to clinical outcomes. First, we aim to determine whether perioperative VEGF levels can serve as a predictive biomarker for CSA- AKI development, severity, and duration. Second, we aim to elucidate the mechanistic pathways through which VEGF influences AKI and recovery in the cardiac surgery setting. Understanding the significance of VEGF in CSA-AKI may identify novel opportunities for risk stratification and possibly therapeutic interventions to improve kidney outcomes in this high-risk patient population.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Elective cardiac surgery using cardiopulmonary bypass
  • Written informed consent

排除标准

  • Pre-existing chronic kidney disease with an eGFR <20 ml/min/1,73m2
  • Usage of VEGF-inhibitors
  • Patients with pre-existing AKI within the last 30 days
  • Patients undergoing one of the following surgeries:
  • Emergency surgery
  • LVAD-implantation
  • Patients after cardiac arrest requiring cardiopulmonary resuscitation within the last 6 months
  • Patients on vasopressors, inotropes or mechanical circulatory support before surgery

研究组 & 干预措施

Elective cardiac surgical patients

结局指标

主要结局

Association of vascular endothelial growth factor (VEGF) levels with postoperative acute kidney injury

时间窗: From baseline to postoperative day 3

次要结局

  • Difference in VEGF levels between patients with and without chronic kidney disease(From Baseline to postoperative day 3)
  • Difference in VEGF levels between patients with transient and persistent acute kidney injury (AKI) after cardiac surgery(Up to 30 days postoperatively)
  • Association of VEGF levels with length of ICU-stay(Up to 30 days postoperatively)
  • Association of VEGF levels with length of hospital stay(Up to 30 days postoperatively)
  • Association of VEGF levels with 30-day all-cause mortality(From enrolment to postoperative day 30)
  • Association of VEGF levels with Major Adverse Kidney Events up to day 30 (MAKE30)(From enrolment to postoperative day 30)
  • Association of VEGF plasma to urine ratio with postoperative AKI(From Baseline to postoperative day 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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