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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01133795
First Posted: May 31, 2010
Last Update Posted: August 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pere Gines, Hospital Clinic of Barcelona
  Purpose
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.

Condition Intervention Phase
Cirrhosis Renal Failure Drug: Midodrine plus Albumin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Administration of Intravenous Albumin and Oral Midodrine on Renal Function in Patients With Cirrhosis and Functional Renal Impairment

Resource links provided by NLM:


Further study details as provided by Pere Gines, Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Changes in glomerular filtration rate assessed by isotopic methods [ Time Frame: at 12 weeks of treatment ]

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

Enrollment: 7
Study Start Date: February 2010
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Albumin Grifols
  • Gutron

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133795


Locations
Spain
Hospital Clinic
Villarroel 170,Barcelona, Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Pere Ginès, MD Hospital Clinic of Barcelona
  More Information

Responsible Party: Pere Gines, chief of hepatology unit, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01133795     History of Changes
Other Study ID Numbers: MAFRI
First Submitted: May 19, 2010
First Posted: May 31, 2010
Last Update Posted: August 18, 2016
Last Verified: August 2016

Keywords provided by Pere Gines, Hospital Clinic of Barcelona:
cirrhosis
renal failure
hepatorenal syndrome
albumine
midodrine

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Renal Insufficiency
Pathologic Processes
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Midodrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action