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

Primary Purpose

Type 2 Hepatorenal Syndrome, Refractory Ascites

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Midodrine, albumin, octreotide LAR
midodrine, octreotide, albumin
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Hepatorenal Syndrome focused on measuring Hepatorenal syndrome, Refractory ascites, Midodrine, Octreotide, Albumin, Cirrhosis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alberta

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Improvement in renal function (creatinine)

Secondary Outcome Measures

Ascites control

Full Information

First Posted
October 13, 2005
Last Updated
December 3, 2007
Sponsor
University of Alberta
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00240045
Brief Title
The Use of Drugs to Improve Kidney Function in Patients With Liver and Kidney Dysfunction
Official Title
The Use of Midodrine, Octreotide and Albumin in Refractory Ascites
Study Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alberta
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Hepatorenal Syndrome, Refractory Ascites
Keywords
Hepatorenal syndrome, Refractory ascites, Midodrine, Octreotide, Albumin, Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Midodrine, albumin, octreotide LAR
Intervention Type
Drug
Intervention Name(s)
midodrine, octreotide, albumin
Intervention Description
midodrine up to 12.5 mg tid, octreotide LAR 20 mg im once, albumin 150 mg q weekly
Primary Outcome Measure Information:
Title
Improvement in renal function (creatinine)
Time Frame
one month
Secondary Outcome Measure Information:
Title
Ascites control
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Bain, MD, FRCPC
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada

12. IPD Sharing Statement

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

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