Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Montefiore Medical Center
- Primary Endpoint
- Incidence of Post-Paracentesis Circulatory Dysfunction (PPCD)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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
Intervention: Fresh Frozen Plasma (FFP) (Biological)
Albumin
Patients undergoing large volume paracentesis with receive 50ml of 25% albumin for every 2 L removed from their abdomen.
Intervention: Albumin (Biological)
Outcomes
Primary Outcomes
Incidence of Post-Paracentesis Circulatory Dysfunction (PPCD)
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported