Sepsis, Endothelial Function, and Lipids in Critically Ill Patients With Liver Failure (the SELLIFA Study) (SELLIFA)
研究概览
详细说明
Early diagnosis of sepsis may be difficult in patients with severe liver failure in the absence of usual warning clinical signs. Furthermore, routine laboratory tests like blood leucocyte count and serum c-reactive protein may be misleading in most of these patients. A great interest is taken in the identification of sepsis biomarkers or sepsis-induced alterations in the inflammation cascade, whose expression is independent of liver function. Determination of such a biomarker may be a useful tool for the early diagnosis of sepsis and may have a prognostic significance in patients with liver failure.
Septic complications in patients with liver failure may induce a disruption of liver microcirculation, which is regulated by several factors acting on endothelial and liver stellate cells. Furthermore, generation of reactive oxygen species results in an oxidative stress on lipids, proteins, and DNA. Lipid peroxidation may contribute to further hepatocellular injury and activation of systemic inflammation cascade. Both endothelial dysfunction and alterations in lipid metabolism may have a role in the prognosis of liver disease and its complications.
The purpose of this prospective observational study is to determine the role of new biomarkers in the diagnosis of sepsis in critically-ill patients with liver failure and to correlate the prognosis of these patients with parameters of endothelial function and lipid metabolism. In addition, the porto-systemic gradient of these parameters will be determined in patients planned for a transjugular intra-hepatic porto-systemic shunt (TIPSS).
An overall number of 120 patients will be enrolled. According to the mode of presentation, the planned number of patients in the different study groups will be as follow : 70 patients with chronic liver failure and acute on chronic liver failure; 20 patients with acute liver failure ; 30 patients post-liver transplantation.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Brussels、比利时、1200
- Cliniques Universitaires St Luc, Université Catholique de Louvain
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria :
- All consecutive patients with a diagnosis of chronic liver failure, acute on chronic liver failure, acute liver failure, or post-liver transplantation ;
- Adult patient aged 18 years or above, and less than 85 ;
- Admission to the ICU for an expected period of > 24 hours or elective admission for TIPSS placement ;
- Informed consent of the patient or nearest relative.
Exclusion Criteria :
- Age less than 18 years and more than 85 ;
- Pregnancy, including HELLP syndrome ;
- Active malignancy with metastases (localised hepatocellular carcinoma is not an exclusion criteria);
- Systemic chemotherapy in the last 4 weeks (trans-arterial chemo-embolisation for localised hepatocellular carcinoma is not an exclusion criteria) ;
- Acquired immunodeficiency syndrome and antiretroviral therapy ;
- Refusal of the patient or nearest relative.
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
合作者和调查者
调查人员
- 研究主任:Pierre-François Laterre, MD、Cliniques Universitaires St Luc, Université Catholique de Louvain
- 首席研究员:Yvan Fleury, MD、Cliniques universitaires Saint-Luc- Université Catholique de Louvain
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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