Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment
MAFRI
Effect of Administration of Intravenous Albumin and Oral Midodrine on Renal Function in Patients With Cirrhosis and Functional Renal Impairment
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2010
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 19, 2010
CompletedFirst Posted
Study publicly available on registry
May 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedAugust 18, 2016
August 1, 2016
6.3 years
May 19, 2010
August 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in glomerular filtration rate assessed by isotopic methods
at 12 weeks of treatment
Secondary Outcomes (4)
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
changes in aldosterone concentration
at 12 weeks of treatment
changes in norepinephrine concentration
at 12 weeks of treatment
Study Arms (1)
Midodrine, Albumin
EXPERIMENTALMidodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks
Interventions
MIdodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks
Eligibility Criteria
You may qualify if:
- Liver Cirrhosis
- Serum Creatinine greater than 1,2 mg/dL
- to have given written informed consent
You may not qualify if:
- pregnancy
- Systolic blood pressure above 150mmHg and/or diastolic blood pressure above 90mmHg
- Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunts
- infection by HIV
- contraindications for albumin and/or midodrine use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clinic
Villarroel 170,Barcelona, Barcelona, 08036, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pere Ginès, MD
Hospital Clinic of Barcelona
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chief of hepatology unit
Study Record Dates
First Submitted
May 19, 2010
First Posted
May 31, 2010
Study Start
February 1, 2010
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
August 18, 2016
Record last verified: 2016-08