Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis

Phase 4WithdrawnNCT03202524

Montefiore Medical Center

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Liver Cirrhosis Ascites Hepatic

Interventions

Fresh Frozen Plasma (FFP)BIOLOGICAL

FFP will be used as a substitute for albumin for the prevention of post-paracentesis circulatory dysfunction.

AlbuminBIOLOGICAL

Albumin will be used for the prevention of post-paracentesis circulatory dysfunction, as is the standard of care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of Post-Paracentesis Circulatory Dysfunction (PPCD)

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

Time frame: 6 Days

Data from ClinicalTrials.gov

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