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| ID | Type | Description | Link |
|---|---|---|---|
| 680800001061 | Other Grant/Funding Number | Grifols (Investigator initiated Sponsored Research) |
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| Name | Class |
|---|---|
| Grifols Shared Services North America, Inc. | INDUSTRY |
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A small, pilot proof-of-concept placebo-controlled trial to explore the effects of albumin on diuresis in patients with cirrhosis, ascites and lower extremity edema. We will additionally investigate albumin's effect on preventing neurohumoral activation, and acute kidney injury after diuresis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albumin first | Active Comparator | Albumin for one dose, followed by at least 14 day washout period, before crossing over to the alternate arm to receive placebo for one dose. | |
| Placebo first | Placebo Comparator | Placebo for one dose, followed by at least 14 day washout period, before crossing over to the alternate arm to receive albumin for one dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin infusion (25% albumin) | Drug | Albumin 25 gram infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fractional excretion of sodium (FENa) | Change in fractional excretion of sodium (FENa) with administration of albumin vs placebo | 6 hours (baseline vs hour 6 after albumin vs placebo administration) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in neuro hormonal markers | Changes in neuro hormonal markers including norepinephrine, renin, aldosterone | 6 hours and 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anahita Rabiee, MD, MHS | Contact | 203-932-5711 | ext.1-5871 | anahita.rabiee@va.gov |
| Lynn F. Buchwalder, M.S. | Contact | 203-932-5711 | ext.1-5871 | Lynn.Buchwalder@va.gov |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Haven VA Medical Center | Recruiting | West Haven | Connecticut | 06516 | United States |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D001201 | Ascites |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
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Proof of concept, randomized, cross over, double-blind placebo-controlled study
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| Normal Saline (0.9% NaCl) |
| Drug |
100 cc of normal saline |
|
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |