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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00240045
First Posted: October 17, 2005
Last Update Posted: December 6, 2007
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.
Collaborator:
Novartis
Information provided by:
University of Alberta
  Purpose

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 Intervention Phase
Type 2 Hepatorenal Syndrome Refractory Ascites Drug: Midodrine, albumin, octreotide LAR Drug: midodrine, octreotide, albumin Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

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

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

Enrollment: 9
Study Start Date: October 2005
Study Completion Date: July 2007
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00240045


Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
University of Alberta
Novartis
Investigators
Principal Investigator: Vincent Bain, MD, FRCPC University of Alberta
  More Information

Responsible Party: Dr. Vince Bain, University of Alberta
ClinicalTrials.gov Identifier: NCT00240045     History of Changes
Other Study ID Numbers: VB-PG-007
First Submitted: October 13, 2005
First Posted: October 17, 2005
Last Update Posted: December 6, 2007
Last Verified: October 2005

Keywords provided by University of Alberta:
Hepatorenal syndrome
Refractory ascites
Midodrine
Octreotide
Albumin
Cirrhosis

Additional relevant MeSH terms:
Ascites
Hepatorenal Syndrome
Pathologic Processes
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Octreotide
Midodrine
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Sympathomimetics
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