Protocol to Assess the Severity of Acute Kidney Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Urine Volume
研究概览
简要总结
The principal objective is to safely determine if we can identify the severity of Acute Kidney Injury (AKI) early in the course of the disease. Once enrolled, we will draw blood and urine for relevant biomarkers. Our goal is to validate if any of these biomarkers can predict the course of AKI (recovery v. RRT v. death)
详细描述
AKI is a very common disease in the intensive care unit. However, despite advances in supportive care, patients with AKI carry a high mortality rate (50% to 70%). The established AKI affects nearly 5 percent of hospitalized persons and as many as 15 percent of critically ill patients. Currently, there are no FDA approved therapeutic agents for the treatment of AKI.
Retrospective studies suggest that the early initiation of renal replacement therapy (RRT) improves outcome. Many clinicians tend to take a "wait and see" approach because they do not want to dialyze a patient who is destined to recover renal function without the need for RRT. Therefore, it is vitally important to know early in the course which patients with AKI are likely to progress to RRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •18 years and older
- •Increase in serum creatinine of 0.3 mg/dl within 48 hours or an increase of greater or equal to 150 to 200% from baseline or sustained oliguria(mean urine output of <0.5 cc/kg/hr for 6 hours within 48 hours)
- •Written informed consent
- •Patients who already have a indwelling bladder catheter
排除标准
- •Voluntary refusal or missing written consent of the patient or the designated legal representative
- •Patients with advanced Chronic Kidney Disease - as defined by a baseline GFR of < 30 ml/min as calculated by the MDRD equation
- •Patients with renal transplantation
- •Pregnancy
- •Patients with an allergy or sensitivity to loop diuretics
- •Patients with a clinical syndrome consistent with pre-renal AKI
- •Defined by fractional excretion of Na of < 1% AND no evidence of the urinary casts, or
- •Patients that are under-resuscitated as deemed by treating clinical team or
- •Patients who are actively bleeding
- •Patients with a clinical syndrome of post-renal AKI
- •Any radiological study that shows hydro-ureter, or
- •Clinical scenario wherein the obstruction is considered a likely possibility of the cause of AKI
研究组 & 干预措施
1
干预措施: Furosemide (Drug)
结局指标
主要结局
Urine Volume
时间窗: Time from furosemide administration to 6 hours after furosemide administration
Urine output measured in ml/hr for first 6 hours after furosemide administration
次要结局
未报告次要终点