Skip to main content
OpenTrials
Completed

NCT Number: NCT01133795

Midodrine and Albumin for Cirrhotic Patients With 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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midodrine plus Albumin

Drug

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

Other names: Albumin Grifols, Gutron

Primary outcomes

  1. Changes in glomerular filtration rate assessed by isotopic methods

    Time frame: at 12 weeks of treatment

Secondary outcomes

  1. changes in arterial pressure as assessed by continuous ambulatory arterial pressure

    Time frame: at 12 weeks of treatment

  2. changes in plasma renin activity

    Time frame: at 12 weeks of treatment

  3. changes in aldosterone concentration

    Time frame: at 12 weeks of treatment

  4. changes in norepinephrine concentration

    Time frame: at 12 weeks of treatment

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Effect of Administration of Intravenous Albumin and Oral Midodrine on Renal Function in Patients With Cirrhosis and Functional Renal Impairment

Acronym: MAFRI

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
May 31, 2010
Registry last updated
Aug 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.