The Effect of Loop Diuretics on Severity and Outcome of Acute Kidney Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 4
- 主要终点
- Receipt of Renal Replacement Therapy (RRT)
研究概览
简要总结
The primary objective is to safely determine if the investigators can identify the severity of Acute Kidney Injury (AKI) early in the course of the disease. Once enrolled the investigators will draw blood and urine for novel and standard biomarkers. The investigators are attempting to determine if these biomarkers can forecast the course of AKI (need for dialysis, death and renal recovery). The investigators seek to determine how well physicians caring for those with AKI can predict the clinical course compared to these novel biomarkers of AKI and if there is an association between clinical course and 3 year patient outcomes.
详细描述
AKI is a very common disease in the setting of critical illness and carries an extremely high morbidity and mortality rate (over 50%). Currently there are no FDA approved therapeutic agents for the treatment of AKI. There is limited prospective evidence to guide nephrologists in terms of which patients will progress to more severe AKI in the setting of early AKI. Similarly, there is no evidence to guide nephrologists in terms of which patients will completely recover their renal function after AKI. Thus we need to know very early in the course of AKI which patients will progress and go on to require renal replacement therapy (RRT). Additionally we will investigating the long term patient outcomes, 2-3 years after the index AKI admission.
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
- •18 yrs or older
- •increase in serum creatinine of 0.3 mg/dl within 48 hours or an increase of greater than or equal to 150% from baseline or sustained oliguria (UOP < 0.5 cc/kg/hr for 6 hours with the last 48hours)
- •written informed consent
- •patients with an indwelling bladder catheter
排除标准
- •Voluntary refusal
- •Patients with advanced chronic kidney disease - as defined by a baseline glomerular filtration rate (GFR) < 30 ml/min (MDRD)
- •history of renal transplant
- •Pregnant patients
- •Allergy / Sensitivity to Loop diuretics (furosemide)
- •Pre-renal AKI
- •defined by a Fractional Excretion of Sodium (FENa) of < 1% and no urinary casts
- •under-resuscitated as per the treating clinical team
- •active bleed
- •Post renal AKI
- •evidence of hydro-ureter
- •clinical scenario wherein obstruction is considered a likely possibility
研究组 & 干预措施
Lasix
Pt to get dose of furosemide after meeting entry criteria - dose dependent on previous exposure to diuretics
干预措施: Furosemide (Drug)
结局指标
主要结局
Receipt of Renal Replacement Therapy (RRT)
时间窗: within 7 days of furosemide administration
The number of patients who received renal replacement therapy (Dialysis)
Progression to Stage 3 AKI
时间窗: within 7 days of furosemide administration
The number of patients who progressed to Stage 3 during the time of observation
Death
时间窗: During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first
Inpatient mortality
次要结局
- Length of Intensive Care Unit (ICU) Stay(During the index hospital stay, an average of 9 days, until ICU discharge, or until death, whatever occurs first)
- Length of Hospital Stay(During the index hospital stay, an average of 17 days, until hospital discharge, or until death, whatever occurs first)