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

NCT ID: NCT00240045

Last Updated: 2007-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-07-31

Brief Summary

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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

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Conditions

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Type 2 Hepatorenal Syndrome Refractory Ascites

Keywords

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Hepatorenal syndrome Refractory ascites Midodrine Octreotide Albumin Cirrhosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Midodrine, albumin, octreotide LAR

Intervention Type DRUG

midodrine, octreotide, albumin

Intervention Type DRUG

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

Interventions

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Midodrine, albumin, octreotide LAR

Intervention Type DRUG

midodrine, octreotide, albumin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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University of Alberta

Principal Investigators

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Vincent Bain, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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VB-PG-007

Identifier Type: -

Identifier Source: org_study_id