Determination of the Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients: TOX-AKI Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Mortality rate
研究概览
简要总结
The development of acute kidney injury (AKI) during septic shock is frequent and is associated with a high mortality rate. The reason of this increased mortality despite the use of renal replacement therapy is still unknown. The deleterious effects of uremic toxins (solutes accumulating with the loss of kidney function) has risen for the last decade in chronic kidney disease patients. Among those solutes, indoxyl sulfate (IS) is associated with the development of cardiovascular complications and impairment of immune response. The role of uremic toxins and particularly IS in the prognostic of septic kidney injury is unknown. The investigators propose to analyze the relation between the serum concentration of IS and the mortality of patients hospitalized for a septic shock who developed an AKI.
详细描述
During chronic kidney disease the uremic toxins have been widely described as potential harmful solutes targeting the cardiovascular system, immunologic system, endothelium and bone metabolism. However, nothing is known about the potential accumulation and pejorative effects of those uremic toxins during AKI (Acute Kidney Injury). The objective of this study is to explore the role of the uremic toxins and specially IS (Indoxyl Sulfate) in the mortality of patients hospitalized for a septic shock and AKI. This study will also describe for the first time the kinetic of the blood concentration of different uremic toxins and their relation with the mortality and the kidney function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients over 18 years hospitalized in the medical intensive care unit in Amiens university hospital
- •Presence of a septic shock (sepsis associated with a persistent hypotension after fluid resuscitation and requiring vasopressors to maintain MAP > 65 mmHg and/or serum lactate level > 2 mmol/ L).
- •Evidence of AKI (KDIGO > or equal1) in the 72 hours following the admission in the ICU: diuresis < 0.5ml / kg / h for 6 to12 hours or > or equal 1.5 to1.9 fold increase or > 26.5 micromol / l in serum creatinine from baseline
- •signed written informed consent form
- •covered by national health insurance
排除标准
- •known pre hospitalization (in the last 3 month preceding the hospitalization) advanced chronic kidney disease defined by an estimated glomerular filtration rate < 60 ml / min / 1.73m square
- •Pregnancy
- •Presence or strong clinical suspicion of renal obstruction
- •Moribund patients (expected life < 48h)
- •Cardio respiratory arrest
- •Hemoglobin level below 10 g / dl
结局指标
主要结局
Mortality rate
时间窗: at day 90 after patient was admitted in intensive care unit
Mortality of patients hospitalized for a septic shock who developed an acute kidney injury
次要结局
- Blood concentration of Klotho(at day 7 after patient was admitted in intensive care unit)
- Blood concentration of para cresyl sulfate (PRS)(at day 7 after patient was admitted in intensive care unit)
- Blood concentration of FGF 23 (Fibroblast Growth Factor 23)(at day 7 after patient was admitted in intensive care unit)
- Blood concentration of indoxyl sulfate(at day 7 after patient was admitted in intensive care unit)