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

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Cirrhosis, Ascites Hepatic

Intervention / Treatment
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* Biological: Fresh Frozen Plasma (FFP)
* Biological: Albumin


Participation Criteria
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Eligibility Criteria
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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 INR > 1.7

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Albumin<br>Patients undergoing large volume paracentesis with receive 50ml of 25% albumin for every 2 L removed from their abdomen. | Biological: Albumin<br>* Albumin will be used for the prevention of post-paracentesis circulatory dysfunction, as is the standard of care<br>|
| Experimental: Fresh Frozen Plasma<br>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 | Biological: Fresh Frozen Plasma (FFP)<br>* FFP will be used as a substitute for albumin for the prevention of post-paracentesis circulatory dysfunction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paracentesis, Albumin, Plasma