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

This study is currently recruiting participants.
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

May 19, 2010
March 3, 2014
February 2010
February 2015   (final data collection date for primary outcome measure)
Changes in glomerular filtration rate assessed by isotopic methods [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01133795 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cirrhosis
  • Renal Failure
Drug: Midodrine plus Albumin
MIdodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks
Other Names:
  • Albumin Grifols
  • Gutron
Experimental: Midodrine, Albumin
Midodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks
Intervention: Drug: Midodrine plus Albumin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Pere Ginès, MD 0034932275400 ext 1713 PGINES@clinic.ub.es
Spain
 
NCT01133795
MAFRI
Yes
Pere Gines, Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
Not Provided
Principal Investigator: Pere Ginès, MD Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP