Role of Renal Cell Arrest and Damage Biomarkers in Progression and Outcome of Sepsis Associated AKI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- progression of AKI
研究概览
简要总结
The aim of the current study is to assess the predictive value of renal cell arrest biomarkers (urinary TIMP2 and IGFBP7), renal damage biomarkers (urinary KIM-1) and microscopic examination of urinary sediment in progression and outcome of sepsis associated AKI.
详细描述
Acute kidney injury occurred in about 45-53% of patients with sepsis, and most septic AKI was mild or moderate AKI (KDIGO stage 1 or stage 2).
However, previous study showed that up to 40% of these mild or moderate AKI would progress to more severe AKI (KDIGO stage 3), of which 30% required dialysis and the risk of death increased by 3-fold, as high as 70%. Therefore, early identifying patients at high risk for progressive AKI might help clinicians to enhance individualized monitoring and personalized management in patient with septic AKI, which might prevent or halt the ongoing renal injury and improve the outcome of patients with sepsis.
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
- •AKI stage 1 or 2 according to KDIGO definition.
- •Sepsis is defined based on the third international consensus definitions for sepsis and septic shock (Sepsis-3) as life threatening organ dysfunction caused by a dysregulated host response to infection. At least two of systemic inflammatory response syndrome (SIRS) criteria should be present
排除标准
- •Age less than 18 years.
- •Patients with pre-existing chronic kidney disease (eGFR<60 ml/min/1.73m2).
- •Previous renal replacement therapy.
- •Acute kidney injury caused by permanent postrenal obstruction.
- •Pregnancy.
- •Hepatorenal syndrome.
- •Renal transplant recipients.
- •Patients for whom survival to 30 days is unlikely due to end stage disease (end stage liver or heart disease or untreatable malignancy).
结局指标
主要结局
progression of AKI
时间窗: 90 days
by assessing change in eGFR
Examination of urine sediment
时间窗: 7 days
by calculating Perazella score
Urinary KIM-1 estimation
时间窗: 90 days
will be measured by the ELISA technique
Urinary TIMP2 and IGFBP7 estimation
时间窗: 90 days
both will be measured by the ELISA technique
次要结局
- need for renal replacement therapy(90 days)
- mortality(90 days)
- length of ICU and hospital stay(90 days)
研究者
Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD
Lecturer
Alexandria University