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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00240045
First received: October 13, 2005
Last updated: December 3, 2007
Last verified: October 2005
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ascites control [ Time Frame: one month ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Vince Bain, University of Alberta
ClinicalTrials.gov Identifier: NCT00240045     History of Changes
Other Study ID Numbers: VB-PG-007
Study First Received: October 13, 2005
Last Updated: December 3, 2007
Health Authority: Canada: Health Canada

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
Midodrine
Octreotide
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 26, 2014