Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Change in plasma renin activity (PRA) post paracentesis
研究概览
简要总结
Large volume paracentesis (LVP) 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 determine if the administration of Fresh Frozen Plasma (FFP) during large volume paracentesis is effective in lowering plasma renin activity by 25% compared to baseline.
详细描述
There will be three periods of this study, one for each of three consecutive routine large volume paracenteses. The length of the study will be 6 days post paracentesis for each period, for a total of 3 periods. The interval between successive LVP's will be determined by patients' need. In order to ensure follow up on Day 6, Day 1 will be restricted to a Tuesday, Wednesday, Thursday, or Friday.
All participants will be monitored for 3 consecutive routine large volume paracenteses. The 3 periods (LVP's) of this study will differ in administration of volume replacement solution. First LVP will be with intravenous albumin (12.5gm 25% Human Albumin for every 2 liters removed), 2nd LVP with administration 1 unit of FFP for every 2 liters removed for the first 4 liters followed by 12.5gm 25% albumin for every subsequent 2 liters removed, and 3rd LVP again with administration of intravenous albumin. The first LVP serves as the study entry time period and also as a control period for the same patient. The second LVP is to test the new intervention with FFP. The third LVP is included so that we can monitor the patient's status.
Albumin or FFP administration:
Albumin administration:
50ml of 25% albumin for every 2L removed
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •INR > 1.7, <2.5
排除标准
- •Inability to obtain informed consent
- •Age less than 18
- •Hepatic Encephalopathy Grade > 1 as defined by the presence of an impaired mental status or the presence of asterixis
- •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
- •Pregnancy - pregnancy test will be administered for all female patients
结局指标
主要结局
Change in plasma renin activity (PRA) post paracentesis
时间窗: 6 Days
Efficacy of LVP with FFP will be measured as the change of plasma renin activity (PRA) from Day 1 to Day 6 during the 2nd LVP with FFP. We hypothesize that FFP will reduce the PRA by 25% from Day 1 to Day 6.
次要结局
- Occurrence of post-paracentesis circulatory dysfunction (PPCD)(6 days)
- Safety: Adverse Events (AE)(6 days)