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the sponsor did not provide the treatment
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The aim of this study is to evaluate the treatment with midodrine, octreotide and albumin during 12 weeks in patients with hepatorenal syndrome. Fifteen patients will be enrolled and followed during 16 weeks. The effects on renal function will be evaluated 12 and 16 weeks after the beginning of the treatment by isotopic evidence and biochemist determinations. Also it will be evaluated arterial pressure and determination of vasoactive hormones (plasma renin, aldosterone and norepinephrine).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albumin, Midodrine, Octreotide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin | Drug | Albumin (20%) 1g/kg iv on day 1 and 80 g every 2 weeks during a period of 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular filtration | Change in glomerular filtration rate measured by isotopic tests | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in plasma renin activity, plasma aldosterone and norepinephrine | 4, 12 and 16 weeks | |
| Changes in blood pressure measured by Holter | 4, 12 and 16 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic i Provincial de Barcelona | Barcelona | 08036 | Spain |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D051437 | Renal Insufficiency |
| D006530 | Hepatorenal Syndrome |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| D008879 | Midodrine |
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
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| Midodrine | Drug | Oral midodrine 5 mg / 8 hours for 12 weeks. The dose may be increased on day 7 10mg/8h. If creatinine does not decrease ≥ 25% and systolic blood pressure is bellow 150 mmHg and diastolic 90 mmHg doses will be changed. |
|
| Octreotide | Drug | Octreotide by subcutaneous injection 0.1 mg every 8 hours for 12 weeks. The dose may be increased to 0.2 mg / 8 h on day 7. If creatinine does not decrease ≥ 25% and systolic blood pressure is bellow 150 mmHg and diastolic 90 mmHg doses will be changed. |
|
| Changes in renal function |
| at 4 weeks after cessation of treatment |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000438 |
| Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |