Searching Biomarkers of Acute Intestinal Ischemic Injuries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 556
- 试验地点
- 1
- 主要终点
- observation of clinical-bio-scanographic pain related to a splanchnic-mesenteric, occlusive or non-occlusive vascular insufficiency, to abdominal CT angiography, in the absence of another identifiable cause
研究概览
简要总结
The aim of the SURVIBIO study is to characterize accurate biomarkers for acute mesenteric ischemia, in particular at early stages.
In the study, the development of biomarkers will be based on the analysis of human biological samples from patients and controls that will be conserved in a biological library. Samples will be analysed in the Laboratory for Vascular Translational Sciences (LVTS, Inserm U1148), in the Department of Biochemistry (Pr Puy, Dr Peoc'h), in Paris V university , in Imperial College of London (Pr Dumas), in Jacques Monod Institute and in Maastricht University Medical Center . The candidate markers will be determined according to an a priori method (form markers already described in the literature) and with no a priori strategy using -omics methods.
详细描述
Acute intestinal ischemic injury (i3), or intestinal infarction, is an extremely severe condition that affects the intestine, with a mortality rate that is over 80%, and with major anatomical and functional consequences for the surviving patients, mainly because of intestinal resections, which are responsible for chronic intestinal failure, long term parenteral nutrition and an important financial impact on public health.
Even though the incidence of i3 is largely underestimated (mainly because of the lack of knowledge of diagnostic), more than 1000 patients have been surveyed in Paris's hospital through Information Systems Medicalization Program (K550) searching in 2014. Furthermore, i3 represents a digestive emergency for which the only known prognostic factors are the precocity of the diagnostic and treatment.
Investigators have opened in January 2016 the first structure for intestinal vascular emergency (SURVI) within the Groups University Hospitals Paris-Nord Val de Seine. This unique and innovative intensive care structure, which is dedicated to the multidisciplinary treatment of acute mesenteric ischemia, doesn't have any equivalent, and allows the constitution of cohorts with biological and tissular bio-banking.
SURVI provides the patients suffering from intestinal ischemia a "gut and life staving strategy", through a multimodal and multidisciplinary management (M3). M3 is based on a simple algorithm and it brings together experts in intestinal and vascular pathologies that come from different medical disciplines, such as gastroenterology, interventional radiology, vascular surgery, digestive surgery, anaesthesiology and cardiology.
Therefore, the therapeutic strategies aim to limit the complications, to protect the viable intestine, and to remove the necrotic intestine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •age> 18 years
- •Acute abdominal pain requiring an injected abdominal injected CT scan, at best at non-injected / early arterial / portal time
- •Admitted or attended in Beaujon and / or Bichat hospitals
- •Patient covered by a social security scheme
- •Written consent
排除标准
- •lack of abdominal CT scan
研究组 & 干预措施
Patient
Any patient admitted for acute abdomen condition with or without ischemic causes.
干预措施: blood sampling (Biological)
witness
干预措施: blood sampling (Biological)
结局指标
主要结局
observation of clinical-bio-scanographic pain related to a splanchnic-mesenteric, occlusive or non-occlusive vascular insufficiency, to abdominal CT angiography, in the absence of another identifiable cause
时间窗: 2 years
次要结局
- Intestinal resection ratio(2 years)
- acute intestinal ischemic injury relapse ratio(2 years)
- short gut syndrome features(2 years)
- persistency of mesenteric ischemia clinical signs or of ischemic gastric stenosis(2 years)
- mortality and causes(2 years)