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

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 2

Conditions: Renal Failure; Cirrhosis

Treatments: Drug: Midodrine plus Albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT01133795

MAFRI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Midodrine, Albumin

Experimental group

Description:

Midodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks

Treatment:

Drug: Midodrine plus Albumin