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The objective of the study was evaluate the effect of administration of midodrine and albumin on renal function in patients with cirrhosis and creatinine greater than 1,2mg/dl.
Twenty patients with cirrhosis and functional renal impairment, defined by a serum creatinine greater than 1,2mg/dl, will be included. Patients will receive daily midodrine at a dose of 10mg tid and 40g of albumin at 15-day interval. The follow-up period will be of 12 weeks. In all patients, liver and renal function, and vasoactive hormones (plasma renin activity, aldosterone, noradrenaline, ADH, endothelin and anf)will be determined at baseline conditions. At this moment, glomerular filtration rate and renal plasma flow determined by isotopic techniques as ambulatory blood pressure monitoring through a 24-hour period will be performed too. All these determinations will be repeated at 4 and 12 weeks. During the study period, just before the albumin infusions, blood will be drawn for creatinine and electrolytes determinations and these will be recorded as well physical examination performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midodrine, Albumin | Experimental | Midodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midodrine plus Albumin | Drug | MIdodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in glomerular filtration rate assessed by isotopic methods | at 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| changes in arterial pressure as assessed by continuous ambulatory arterial pressure | at 12 weeks of treatment | |
| changes in plasma renin activity | at 12 weeks of treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pere Ginès, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic | Villarroel 170,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 |
|---|---|
| D008879 | Midodrine |
| D000418 | Albumins |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| changes in aldosterone concentration |
| at 12 weeks of treatment |
| changes in norepinephrine concentration | at 12 weeks 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 |
| D000588 |
| Amines |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |