NCT00240045

The Use of Drugs to Improve Kidney Function in Patients With Liver and Kidney Dysfunction

The Use of Midodrine, Octreotide and Albumin in Refractory Ascites

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

We will address the hypothesis that refractory ascites and Type 2 hepatorenal syndrome are mediated in part by diminished circulatory volume and that treatment with midodrine, octreotide and albumin can improve renal and patient outcomes by restoring effective circulating volume and systemic perfusion. Our primary objective is to assess change in creatinine clearance using inulin. We will enroll 15 patients with Type 2 hepatorenal syndrome or refractory ascites once inclusion and exclusion criteria are satisfied. They will be treated for 1 month with octreotide LAR, albumin and midodrine. Renal, serum and neurohormonal parameters will be measured before, during, and after initiation of drug and compared.

Conditions

• Type 2 Hepatorenal Syndrome
• Refractory Ascites

Interventions

Type	Name	Description
DRUG	Midodrine, albumin, octreotide LAR
DRUG	midodrine, octreotide, albumin	midodrine up to 12.5 mg tid, octreotide LAR 20 mg im once, albumin 150 mg q weekly

Timeline

• Start date: 2005-10-01
• Completion: 2007-07-01
• First posted: 2005-10-17
• Last updated: 2007-12-06

Locations

1 site across 1 country: Canada