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

Primary Purpose

Cirrhosis, Renal Failure

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Midodrine plus Albumin
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis focused on measuring cirrhosis, renal failure, hepatorenal syndrome, albumine, midodrine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Midodrine, Albumin

Arm Description

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

Outcomes

Primary Outcome Measures

Changes in glomerular filtration rate assessed by isotopic methods

Secondary Outcome Measures

changes in arterial pressure as assessed by continuous ambulatory arterial pressure
changes in plasma renin activity
changes in aldosterone concentration
changes in norepinephrine concentration

Full Information

First Posted
May 19, 2010
Last Updated
August 17, 2016
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT01133795
Brief Title
Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment
Acronym
MAFRI
Official Title
Effect of Administration of Intravenous Albumin and Oral Midodrine on Renal Function in Patients With Cirrhosis and Functional Renal Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Renal Failure
Keywords
cirrhosis, renal failure, hepatorenal syndrome, albumine, midodrine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Midodrine, Albumin
Arm Type
Experimental
Arm Description
Midodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Midodrine plus Albumin
Other Intervention Name(s)
Albumin Grifols, Gutron
Intervention Description
MIdodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks
Primary Outcome Measure Information:
Title
Changes in glomerular filtration rate assessed by isotopic methods
Time Frame
at 12 weeks of treatment
Secondary Outcome Measure Information:
Title
changes in arterial pressure as assessed by continuous ambulatory arterial pressure
Time Frame
at 12 weeks of treatment
Title
changes in plasma renin activity
Time Frame
at 12 weeks of treatment
Title
changes in aldosterone concentration
Time Frame
at 12 weeks of treatment
Title
changes in norepinephrine concentration
Time Frame
at 12 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pere Ginès, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic
City
Villarroel 170,Barcelona
State/Province
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

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Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment

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