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

NCT00240045 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2007-12-06

No results posted yet for this study

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.

Conditions

  • Type 2 Hepatorenal Syndrome
  • Refractory Ascites

Interventions

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

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • University of Alberta

    lead OTHER

Principal Investigators

  • Vincent Bain, MD, FRCPC · University of Alberta

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Completion
2007-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00240045 on ClinicalTrials.gov