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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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We will address the hypothesis that refractory ascites and Type 2 hepatorenal syndrome are mediated in part by diminished circulatory volume and that treatment with midodrine, octreotide and albumin can improve renal and patient outcomes by restoring effective circulating volume and systemic perfusion.
Our primary objective is to assess change in creatinine clearance using inulin. We will enroll 15 patients with Type 2 hepatorenal syndrome or refractory ascites once inclusion and exclusion criteria are satisfied. They will be treated for 1 month with octreotide LAR, albumin and midodrine. Renal, serum and neurohormonal parameters will be measured before, during, and after initiation of drug and compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midodrine, albumin, octreotide LAR | Drug |
| ||
| midodrine, octreotide, albumin |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in renal function (creatinine) | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Ascites control | one month |
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Inclusion Criteria:
Type 2 hepatorenal syndrome and/or refractory ascites
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Bain, MD, FRCPC | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | T6G 2E1 | Canada |
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| ID | Term |
|---|---|
| D001201 | Ascites |
| D006530 | Hepatorenal Syndrome |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D008879 | Midodrine |
| D000418 | Albumins |
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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midodrine up to 12.5 mg tid, octreotide LAR 20 mg im once, albumin 150 mg q weekly |
|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000588 |
| Amines |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |