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

Refractory Ascites Clinical Trial

Official title:

The Use of Midodrine, Octreotide and Albumin in Refractory Ascites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240045
• Other study ID #: VB-PG-007
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 13, 2005
• Last updated: December 3, 2007
• Start date: October 2005
• Est. completion date: July 2007

Study information

• Verified date: October 2005
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Cirrhosis (biopsy or compatible clinical (ascites, varices), laboratory (low albumin, elevated bilirubin, elevated INR) and radiologic data (nodular appearing liver on ultrasound)).

Type 2 hepatorenal syndrome and/or refractory ascites

Exclusion Criteria:

• Secondary causes of renal dysfunction (proteinuria >500 mg/day, active urinary sediment, abnormal renal ultrasound, nephrotoxic medications) Bacterial infection (positive blood, urine or ascites cultures) within the past 2 weeks Gastrointestinal hemorrhage or encephalopathy within the past 2 weeks Age <18 Transvenous intrahepatic portosystemic stent shunt (TIPS) Hepatocellular carcinoma beyond the Milan criteria

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Hepatorenal Syndrome
• Refractory Ascites
• Type 2 Hepatorenal Syndrome

Intervention

Drug:
• Midodrine, albumin, octreotide LAR

• midodrine, octreotide, albumin
midodrine up to 12.5 mg tid, octreotide LAR 20 mg im once, albumin 150 mg q weekly

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Novartis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in renal function (creatinine)		one month	No
Secondary	Ascites control		one month	No