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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Hospital Clinic of Barcelona
Sponsor:
Information provided by (Responsible Party):
Pere Gines, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01133795
First received: May 19, 2010
Last updated: March 3, 2014
Last verified: March 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Changes in glomerular filtration rate assessed by isotopic methods [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in arterial pressure as assessed by continuous ambulatory arterial pressure [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]
  • changes in plasma renin activity [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]
  • changes in aldosterone concentration [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]
  • changes in norepinephrine concentration [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: February 2015 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133795

Contacts
Contact: Pere Ginès, MD 0034932275400 ext 1713 PGINES@clinic.ub.es

Locations
Spain
Hospital Clinic Recruiting
Villarroel 170,Barcelona, Barcelona, Spain, 08036
Sub-Investigator: Mónica Guevara, MD         
Sub-Investigator: Gustavo H Pereira, MD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Pere Ginès, MD Hospital Clinic of Barcelona
  More Information

No publications provided

Responsible Party: Pere Gines, chief of hepatology unit, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01133795     History of Changes
Other Study ID Numbers: MAFRI
Study First Received: May 19, 2010
Last Updated: March 3, 2014
Health Authority: Spain: Spanish Agency of Medicines

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

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

ClinicalTrials.gov processed this record on October 30, 2014