Ascites Hepatic, Liver Cirrhosis
Conditions
Keywords
Paracentesis, Albumin, Plasma
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.
Interventions
BIOLOGICALFresh Frozen Plasma (FFP)
FFP will be used as a substitute for albumin for the prevention of post-paracentesis circulatory dysfunction.
BIOLOGICALAlbumin
Albumin will be used for the prevention of post-paracentesis circulatory dysfunction, as is the standard of care
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Control Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older 2. Cirrhosis of the liver based on biopsy or clinical and radiographic criteria 3. Ability to provide informed consent (Grade 0 to 1 HE) 4. Grade 3 ascites or refractory ascites 5. Ascites requiring frequent large volume paracentesis of at least 5 liters at least once a month 6. No diuretic use
Exclusion criteria
1. Inability to obtain informed consent 2. Age less than 18 3. Hepatic Encephalopathy Grade \> 1 4. Septic shock 5. Active infection 6. Respiratory failure 7. Heart failure with reduced ejection fraction of ≤ 50% 8. Moderate or severe pulmonary hypertension 9. History of stroke 10. Unstable coronary artery disease 11. Chronic kidney disease (GFR \<60) 12. GI bleed within 2 weeks 13. Any licorice within 2 weeks of starting the study 14. Any Beta Blocker use within the last 2 weeks 15. Any diuretic use within 2 weeks 16. Absence of paracentesis within 2 weeks 17. Absence of volume expanders within 2 weeks 18. INR \> 1.7
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post-Paracentesis Circulatory Dysfunction (PPCD) | 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 |
Outcome results
None listed