NCT03202524
Withdrawn
Phase 4
Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Liver Cirrhosis
- Sponsor
- Montefiore Medical Center
- Primary Endpoint
- Incidence of Post-Paracentesis Circulatory Dysfunction (PPCD)
- Status
- Withdrawn
- Last Updated
- 6 years ago
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.
Investigators
Eligibility Criteria
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
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
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