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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00240045
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : December 6, 2007
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Type 2 Hepatorenal Syndrome Refractory Ascites Drug: Midodrine, albumin, octreotide LAR Drug: midodrine, octreotide, albumin Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Midodrine, Octreotide and Albumin in Refractory Ascites
Study Start Date : October 2005
Actual Study Completion Date : July 2007

Arm Intervention/treatment
Experimental: 1 Drug: Midodrine, albumin, octreotide LAR
Drug: midodrine, octreotide, albumin
midodrine up to 12.5 mg tid, octreotide LAR 20 mg im once, albumin 150 mg q weekly

Primary Outcome Measures :
  1. Improvement in renal function (creatinine) [ Time Frame: one month ]

Secondary Outcome Measures :
  1. Ascites control [ Time Frame: one month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00240045

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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
University of Alberta
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Principal Investigator: Vincent Bain, MD, FRCPC University of Alberta

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Responsible Party: Dr. Vince Bain, University of Alberta Identifier: NCT00240045    
Other Study ID Numbers: VB-PG-007
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: December 6, 2007
Last Verified: October 2005
Keywords provided by University of Alberta:
Hepatorenal syndrome
Refractory ascites
Additional relevant MeSH terms:
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Hepatorenal Syndrome
Pathologic Processes
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action