Kidney and Intestinal Markers for Early Detection of Organ Injury After Endovascular Aortic Repair - The KISMED Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Level of biomarkers of abdominal organ injury (plasmatic i-FABP, TIMP-2, IGFBP7)
研究概览
简要总结
This study aims to investigate the predictive value of novel biomarkers and contrast-enhanced ultrasonography for early detection of abdominal end-organ (kidney and intestinum) hypoperfusion and ischemia in patients undergoing endovascular aortic repair (EVAR) for aortic aneurysm or dissection. In this context, patients will be monitored for renal biomarkers (TIMP-2, IGFBP7) and intestinal biomarkers (plasmatic intestinal fatty acid binding protein (i-FABP)) and local tissue perfusion will be assessed using contrast-enhanced ultrasonography (CEUS).
The ultimate goal of this study is an early identification of patients developing one or both of these complications, which may facilitate a timely intervention to improve outcome.
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
- 否
入选标准
- •Existence of an aortic aneurysm with need of repair as indicated by the treating vascular surgeon
- •Aortic stenting involving the origin of both mesenteric (i.e. superior and inferior mesenteric arteries) and kidney arteries
- •Central line is present to perform repeated blood collections
- •Written informed consent is obtained.
排除标准
- •Pre-existing severe liver or kidney injury (defined as spontaneous international normalized ratio (INR) >2 or creatinine >2 mg/dl or renal-replacement therapy in the pre-operative course.)
- •Known allergy to ultrasound contrast media (exclusion for the CEUS but not for marker evaluation)
- •Anemia with hemoglobin concentration < 7g/dl
- •Patients < 18 years of age
- •Patients not able to give written informed consent
结局指标
主要结局
Level of biomarkers of abdominal organ injury (plasmatic i-FABP, TIMP-2, IGFBP7)
时间窗: 48hours post surgery
The primary objective of this study is to evaluate the early post-operative course of kidney and intestinal biomarkers in patients following EVAR and their value for prediction of development of acute kidney injury or acute mesenteric ischemia.
次要结局
- Incidence of acute kidney injury (AKI)(first 48 hours post surgery)
- Local tissue perfusion and microcirculation as quantified by CEUS(48 hours post surgery)
- Localization and incidence of intestinal ischemia(first 48 hours post surgery)
研究者
Professor Hans-Jürgen Schlitt
Prof. Dr. Hans J. Schlitt
University Hospital Regensburg