Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Administration of Intravenous Albumin and Oral Midodrine on Renal Function in Patients With Cirrhosis and Functional Renal Impairment

Conditions
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Cirrhosis, Renal Failure

Intervention / Treatment
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* Drug: Midodrine plus Albumin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver Cirrhosis Serum Creatinine greater than 1,2 mg/dL to have given written informed consent Exclusion Criteria: pregnancy Systolic blood pressure above 150mmHg and/or diastolic blood pressure above 90mmHg Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunts Antibiotic treatment in the previous 7 days before inclusion, except for prophylaxis of spontaneous bacterial peritonitis infection by HIV contraindications for albumin and/or midodrine use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midodrine, Albumin<br>Midodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks | Drug: Midodrine plus Albumin<br>* MIdodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks<br>* Other names: Gutron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in glomerular filtration rate assessed by isotopic methods |  | at 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| changes in aldosterone concentration |  | at 12 weeks of treatment | 
| changes in norepinephrine concentration |  | at 12 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cirrhosis, renal failure, hepatorenal syndrome, albumine, midodrine