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

August 17, 2016 updated by: Pere Gines, Hospital Clinic of Barcelona

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Villarroel 170,Barcelona, Barcelona, Spain, 08036
        • Hospital Clínic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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:
  • Gutron
  • Albumin Grifols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in glomerular filtration rate assessed by isotopic methods
Time Frame: at 12 weeks of treatment
at 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in arterial pressure as assessed by continuous ambulatory arterial pressure
Time Frame: at 12 weeks of treatment
at 12 weeks of treatment
changes in plasma renin activity
Time Frame: at 12 weeks of treatment
at 12 weeks of treatment
changes in aldosterone concentration
Time Frame: at 12 weeks of treatment
at 12 weeks of treatment
changes in norepinephrine concentration
Time Frame: at 12 weeks of treatment
at 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Pere Ginès, MD, Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 28, 2010

First Posted (ESTIMATE)

May 31, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 18, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAFRI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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