Status:
COMPLETED
The Use of Drugs to Improve Kidney Function in Patients With Liver and Kidney Dysfunction
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Novartis
Conditions:
Type 2 Hepatorenal Syndrome
Refractory Ascites
Eligibility:
All Genders
19+ years
Phase:
PHASE2
PHASE3
Brief 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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00240045
Start Date
October 1 2005
End Date
July 1 2007
Last Update
December 6 2007
Active Locations (1)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1