Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment

NCT ID: NCT01133795

Last Updated: 2016-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2016-06-30

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.

Conditions

Cirrhosis; Renal Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Midodrine, Albumin

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

Group Type: EXPERIMENTAL

Midodrine plus Albumin

Intervention Type: DRUG

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

Interventions

Midodrine plus Albumin

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

Intervention Type: DRUG

Other Intervention Names

Albumin Grifols; Gutron

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Pere Gines

chief of hepatology unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pere Ginès, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

Hospital Clinic

Villarroel 170,Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

MAFRI

Identifier Type: -

Identifier Source: org_study_id