Comparison of Diuretic Effect With Furosemide Alone Versus the Combination of Furosemide and Albumin in Cirrhotic Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in Weight
研究概览
简要总结
A common complication of the progression of cirrhosis is fluid retention (ascites, edema, or pleural effusion). Loop diuretics are the treatment of choice for fluid retention in cirrhotic patients; however, many of these patients demonstrate diuretic resistance, requiring higher doses of the diuretics to achieve adequate diuresis. The cause of this diuretic resistance is hypothesized to be secondary to hypoalbuminemia which has led some providers to give human albumin in combination with loop diuretics to increase intravascular volume and facilitate diuresis. However, this practice remains controversial because minimal data exists to support its efficacy. The purpose of this study is to compare the efficacy of diuretics alone versus diuretics in combination with albumin in cirrhotic patients presenting with fluid retention.
详细描述
The purpose of this single center, prospective study is to compare the efficacy of two strategies for diuresis in patients with cirrhosis, the use of furosemide (Lasix®) alone versus the combination of furosemide (Lasix ®) and albumin (25%). The investigators will perform a single-center, prospective study with data collected as result of standard of care at Rush University Medical Center (RUMC). Patients who are 18 years of age and older, have diagnosed cirrhosis, and present to RUMC with fluid retention will be identified by the Hepatology and/or Surgery attending and be screened for inclusion in the study. Each patient will be randomized into one of the two cohorts and will have 50% chance of being placed into either cohort. Cohort 1 will receive furosemide (Lasix) 40 to 80 mg intravenous push (IVP) twice a day (BID) for at least 48 hours and cohort 2 will receive combination of furosemide (Lasix) 40 to 80 mg IVP BID and albumin (25%) 12.5 grams BID for at least 48 hours.
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
- 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
- •Adult patients (age >18 years old)
- •Diagnosis of cirrhosis
- •Presents with fluid retention as defined as ascites, edema, or pulmonary effusions requiring diuresis.
排除标准
- •Patients who are younger than 18 years of age
- •Patients who are currently pregnant
- •Patients who present with a serum creatinine greater than 2 mg/dL
研究组 & 干预措施
Furosemide (Lasix) alone
Cohort 1 will receive furosemide (Lasix) 40 to 80 mg IVP BID for at least 48 hours
干预措施: Furosemide Injection (Drug)
Combination of furosemide (Lasix) and albumin
Cohort 2 will receive combination of furosemide (Lasix) 40 to 80 mg IVP BID and albumin (25%) 12.5 grams IV BID for at least 48 hours
干预措施: Furosemide Injection (Drug)
Combination of furosemide (Lasix) and albumin
Cohort 2 will receive combination of furosemide (Lasix) 40 to 80 mg IVP BID and albumin (25%) 12.5 grams IV BID for at least 48 hours
干预措施: Albumin Human (Drug)
结局指标
主要结局
Change in Weight
时间窗: 2-7 days
Change in weight defined as weight loss of 1 kilogram
Amount of Urine
时间窗: 2-7 days
The amount of urine produced over 24 hours.
次要结局
- Change in Serum Creatinine(Through completion of study, up to an average of 1 year)
- Hospital Length of Stay(Through completion of study, up to an average of 1 year)
- 30-day Readmission Rates(30 days from discharge)
- Patient Survival(1 year)