Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment

Cirrhosis Clinical Trial

— MAFRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133795
• Other study ID #: MAFRI
• Status: Completed
• Phase: Phase 2
• First received: May 19, 2010
• Last updated: August 17, 2016
• Start date: February 2010
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis
• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• Midodrine plus Albumin
MIdodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks

Locations

Country	Name	City	State
Spain	Hospital Clinic	Villarroel 170,Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in glomerular filtration rate assessed by isotopic methods		at 12 weeks of treatment	No
Secondary	changes in arterial pressure as assessed by continuous ambulatory arterial pressure		at 12 weeks of treatment	No
Secondary	changes in plasma renin activity		at 12 weeks of treatment	No
Secondary	changes in aldosterone concentration		at 12 weeks of treatment	No
Secondary	changes in norepinephrine concentration		at 12 weeks of treatment	No