Prevention of Acute Renal Injury in the Septic Patient by Implementing the KDIGO Guideline in High-risk Patients Identified by Biomarkers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Compare the incidence of moderate-severe acute renal injury
研究概览
简要总结
Summary: Controlled, prospective, randomized and randomized clinical trial of two intervention groups (standard care vs. preventive recommendations the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for AKI) of patients diagnosed with sepsis and abdominal post-surgical septic shock with positive results in the risk determination of acute renal injury by NephroCheck® Test that integrates the urinary biomarkers TIMP-2 and IGFBP-7.
Hypothesis: The implementation of a package of preventive measures proposed by the KDIGO guide can reduce the occurrence and severity of acute renal injury in the high-risk abdominal post-surgical septic patient detected by urinary biomarkers for early detection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients older than 18 years.
- •Patients (or their informed family members) who accept and sign the informed consent.
- •Patients diagnosed with sepsis or abdominal post-surgical septic shock.
排除标准
- •Patients under 18 years.
- •Patients (or their authorized relatives) who refuse to sign the informed consent.
- •Patients diagnosed with sepsis or non-surgical septic shock.
- •Patients diagnosed with sepsis or septic shock of origin other than abdominal.
- •Patients with AKI stages KDIGO 2 and 3 and / or renal replacement therapy.
- •Patients with chronic renal failure and glomerular filtration <30 ml / min and / or undergoing treatment with dialysis or previous renal transplantation.
- •Patients with AKI of origin other than the diagnosed septic, such as glomerulonephritis or interstitial nephritis, renal artery occlusion and / or postrenal obstruction.
结局指标
主要结局
Compare the incidence of moderate-severe acute renal injury
时间窗: 72 hours
Compare the incidence of moderate-severe acute renal injury (stages KDIGO 2 and 3) in the first 72 hours of diagnosis of sepsis and septic post-surgical septic shock in patients at high risk of AKI determined by NephroCheck® Test (those with a ≥0.3 ng / ml2 / 1000 result) that the package of preventive measures proposed by the KDIGO guideline is applied vs. standard treatment
次要结局
- Compare the number of participants in need of renal replacement therapy(90 days)
- Compare the number of days of stay in the Surgical ICU(90 days)
- Compare mortality from any cause(90 days)
- Compare the number of participants with persistent renal dysfunction(90 days)
- Compare the number of days of stay in the hospital(90 days)
- Measure the incidence of development of AKI in patients at low risk of AKI determined by NephroCheck® Test(72 hours)
研究者
María Mercader Alarcón
Principal Investigator
Hospital General Universitario Elche