Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment (MAFRI)

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cirrhosis; Renal Failure	Drug: Midodrine plus Albumin	Phase 2

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	7 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Effect of Administration of Intravenous Albumin and Oral Midodrine on Renal Function in Patients With Cirrhosis and Functional Renal Impairment
Study Start Date :	February 2010
Actual Primary Completion Date :	June 2016
Actual Study Completion Date :	June 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Midodrine, Albumin; Midodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks	Drug: Midodrine plus Albumin; MIdodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks; Other Names: Albumin Grifols; Gutron

Outcome Measures

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Primary Outcome Measures :

1. Changes in glomerular filtration rate assessed by isotopic methods [ Time Frame: at 12 weeks of treatment ]

Secondary Outcome Measures :

1. changes in arterial pressure as assessed by continuous ambulatory arterial pressure [ Time Frame: at 12 weeks of treatment ]
2. changes in plasma renin activity [ Time Frame: at 12 weeks of treatment ]
3. changes in aldosterone concentration [ Time Frame: at 12 weeks of treatment ]
4. changes in norepinephrine concentration [ Time Frame: at 12 weeks of treatment ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

Spain
Hospital Clinic
Villarroel 170,Barcelona, Barcelona, Spain, 08036

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

Principal Investigator:	Pere Ginès, MD	Hospital Clinic of Barcelona

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Pere Gines, chief of hepatology unit, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT01133795 History of Changes
Other Study ID Numbers:	MAFRI
First Posted:	May 31, 2010
Last Update Posted:	August 18, 2016
Last Verified:	August 2016

Keywords provided by Pere Gines, Hospital Clinic of Barcelona:

cirrhosis; renal failure; hepatorenal syndrome; albumine; midodrine

Additional relevant MeSH terms:

Fibrosis; Liver Cirrhosis; Renal Insufficiency; Pathologic Processes; Liver Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Midodrine; Sympathomimetics	Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Vasoconstrictor Agents; Adrenergic alpha-1 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action