Effect of Probiotics and Prebiotics in Renal Function in Septic Acute Kidney Injury Patients, Randomized Control Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Serum creatinine
研究概览
简要总结
Septic acute kidney injury is a condition associated with highly related to inflammatory molecules. Prebiotics and probiotics have shown to improve inflammatory cascade in animal model; In this study, the investigators propose the use of probiotics to improve the clinical evolution of septic acute kidney injury patients.
详细描述
Acute kidney injury is most commonly caused by sepsis, where endotoxemia and an expanding inflammatory reaction play a key role in its pathogenesis, when this condition is present it is highly related to poor clinical outcomes and higher mortality rates. There is no current specific treatment, and the therapeutic approach is more orientated to complication management. In this study, the investigators propose the use of probiotics to improve the clinical evolution of septic acute kidney injury patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Sepsis by SOFA
- •Acute kidney injury by KDIGO
排除标准
- •No presence of sepsis
- •No presence of AKI
- •Age below 18 years
- •Inability or contraindication for oral capsules or probiotics by nasogastric tube
研究组 & 干预措施
Probiotics. Intervention patients
This patients will receive 2 doses of oral probiotics a day, for seven days
干预措施: Probiotics (Biological)
Placebo group
This patients will receive 2 doses of oral placebo a day, for seven days
干预措施: Placebo (Other)
结局指标
主要结局
Serum creatinine
时间窗: 7 days
Number of participants with significative reduction of serum creatinine concentration from beginning of the intervention
次要结局
- Length of hospitalization(7 days)
- Renal replacement therapy(7 days)
- Urinary output (final)(7 days)
- Death(7 days)
- Final creatinine(7 days)
- Shock days(7 days)
- Recuperation of basal creatinine(7 days)
研究者
Jonathan Samuel Chavez Iñiguez
MD, Nephrologist, Principal investigator
Hospital Civil de Guadalajara