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

Phase 2

Completed

• Conditions: Refractory Ascites; Type 2 Hepatorenal Syndrome
• Interventions: Drug: Midodrine, albumin, octreotide LAR; Drug: midodrine, octreotide, albumin

• Registration Number: NCT00240045
• Lead Sponsor: University of Alberta

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-10
• Study Start: 2005-10
• Study First Submitted: 2005-10-13
• Study First Submitted QC: 2005-10-13
• Study First Posted: 2005-10-17
• Study Completion: 2007-07
• Last Update Submitted: 2007-12-03
• Last Update Posted: 2007-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	midodrine, octreotide, albumin	-
1	Midodrine, albumin, octreotide LAR	-

Primary Outcome Measures

Name	Time	Method
Improvement in renal function (creatinine)	one month

Secondary Outcome Measures

Name	Time	Method
Ascites control	one month

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada