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Study was never approved by the IRB
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albumin | Active Comparator | Patients undergoing large volume paracentesis with receive 50ml of 25% albumin for every 2 L removed from their abdomen. |
|
| Fresh Frozen Plasma | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fresh Frozen Plasma (FFP) | Biological | FFP will be used as a substitute for albumin for the prevention of post-paracentesis circulatory dysfunction. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Sigal, MD | Montefiore Medical Center | Principal Investigator |
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Data collected during the study will only be shared with researchers approved to key-personnel on the study protocol.
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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Randomized Control Trial
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| Albumin | Biological | Albumin will be used for the prevention of post-paracentesis circulatory dysfunction, as is the standard of care |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |