Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment

Phase 2

Completed

• Conditions: Cirrhosis; Renal Failure
• Interventions: Drug: Midodrine plus Albumin

• Registration Number: NCT01133795
• Lead Sponsor: Hospital Clinic of Barcelona

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.

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-05-19
• Study First Submitted QC: 2010-05-28
• Study First Posted: 2010-05-31
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Midodrine, Albumin	Midodrine plus Albumin	Midodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes in glomerular filtration rate assessed by isotopic methods	at 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
changes in aldosterone concentration	at 12 weeks of treatment
changes in norepinephrine concentration	at 12 weeks of treatment
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

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Villarroel 170,Barcelona, Barcelona, Spain