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Dextran, a Plasma Expander, Offers New Hope for Patients With Decompensated Liver Cirrhosis and Acute Kidney Injury

Primary Purpose

Cirrhosis, Liver, AKI

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dextran 40
Sponsored by
Ramathibodi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis, Liver focused on measuring Cirrhosis, AKI, Albumin, Dextran

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Decompensated cirrhosis with acute kidney injury
  • Ager over 18 years old

Exclusion Criteria:

  • Having chronic kidney disease, severe heart or lung disease, severe sepsis
  • Pregnant
  • Receiving nephrotoxic agents
  • Having history of allergic to Dextran

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Dextran 40

    Arm Description

    Dextran 40 infusion

    Outcomes

    Primary Outcome Measures

    AKI reversal
    Reducing creatinine to below 1.5 mg/dl

    Secondary Outcome Measures

    Mortality
    Death

    Full Information

    First Posted
    February 28, 2017
    Last Updated
    February 28, 2017
    Sponsor
    Ramathibodi Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03070353
    Brief Title
    Dextran, a Plasma Expander, Offers New Hope for Patients With Decompensated Liver Cirrhosis and Acute Kidney Injury
    Official Title
    Dextran, a Plasma Expander, Offers New Hope for Patients With Decompensated Liver Cirrhosis and Acute Kidney Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2015 (Actual)
    Primary Completion Date
    June 30, 2016 (Actual)
    Study Completion Date
    June 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ramathibodi Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A pilot study of Dextran-40 infusion in patients with decompensated cirrhosis presenting with AKI
    Detailed Description
    A pilot study of Dextran-40 infusion in decompensated cirrhotic patients complicating with AKI. Dextran-40® was administered at 1 g/kg/day for two days. AKI reversal was defined when serum creatinine was < 1.5 mg/dL. Albumin infusion was given if AKI reversal did not occur.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cirrhosis, Liver, AKI
    Keywords
    Cirrhosis, AKI, Albumin, Dextran

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Model Description
    Focus on clinical response after receiving treatment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dextran 40
    Arm Type
    Experimental
    Arm Description
    Dextran 40 infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Dextran 40
    Other Intervention Name(s)
    Colloidal plasma expander
    Intervention Description
    Dextran-40 infusion with the dose of 1 g/kg/day (10 ml/kg/day) for 2 days.
    Primary Outcome Measure Information:
    Title
    AKI reversal
    Description
    Reducing creatinine to below 1.5 mg/dl
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    Mortality
    Description
    Death
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Decompensated cirrhosis with acute kidney injury Ager over 18 years old Exclusion Criteria: Having chronic kidney disease, severe heart or lung disease, severe sepsis Pregnant Receiving nephrotoxic agents Having history of allergic to Dextran
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Abhasnee Sobhonslidsuk, MD
    Organizational Affiliation
    Ramathibodi Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD will be provided if directly contact with investigator
    Citations:
    PubMed Identifier
    20953964
    Citation
    Niemi TT, Miyashita R, Yamakage M. Colloid solutions: a clinical update. J Anesth. 2010 Dec;24(6):913-25. doi: 10.1007/s00540-010-1034-y. Epub 2010 Oct 17.
    Results Reference
    result

    Learn more about this trial

    Dextran, a Plasma Expander, Offers New Hope for Patients With Decompensated Liver Cirrhosis and Acute Kidney Injury

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