Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Incidence of Post-Paracentesis Circulatory Dysfunction (PPCD)
研究概览
简要总结
Large volume paracentesis with albumin administration is the standard of care for patients with refractory ascites complicating end-stage liver disease. However, the use of albumin is frequently limited due to expense and occasional short supply. The goal of this study is to demonstrate if the administration of fresh frozen plasma (FFP) is as effective as albumin for volume expansion at the time of a large volume paracentesis.
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
- •Age 18 years or older
- •Cirrhosis of the liver based on biopsy or clinical and radiographic criteria
- •Ability to provide informed consent (Grade 0 to 1 HE)
- •Grade 3 ascites or refractory ascites
- •Ascites requiring frequent large volume paracentesis of at least 5 liters at least once a month
- •No diuretic use
排除标准
- •Inability to obtain informed consent
- •Age less than 18
- •Hepatic Encephalopathy Grade > 1
- •Septic shock
- •Active infection
- •Respiratory failure
- •Heart failure with reduced ejection fraction of ≤ 50%
- •Moderate or severe pulmonary hypertension
- •History of stroke
- •Unstable coronary artery disease
- •Chronic kidney disease (GFR <60)
- •GI bleed within 2 weeks
- •Any licorice within 2 weeks of starting the study
- •Any Beta Blocker use within the last 2 weeks
- •Any diuretic use within 2 weeks
- •Absence of paracentesis within 2 weeks
- •Absence of volume expanders within 2 weeks
研究组 & 干预措施
Albumin
Patients undergoing large volume paracentesis with receive 50ml of 25% albumin for every 2 L removed from their abdomen.
干预措施: Albumin (Biological)
Fresh Frozen Plasma
Patients undergoing large volume paracentesis with receive 2 units of FFP for the first 4L removed followed by 50ml of 25% albumin for every additional 2 L removed
干预措施: Fresh Frozen Plasma (FFP) (Biological)
结局指标
主要结局
Incidence of Post-Paracentesis Circulatory Dysfunction (PPCD)
时间窗: 6 Days
The development of PPCD is diagnosed by an increase in plasma renin activity of more than 50% of baseline to \> 4 ng/mL/h on the 6th day post paracentesis
次要结局
未报告次要终点