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

Sponsor
Ramathibodi Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03070353
Collaborator
(none)
10
Enrollment
1
Arm
12
Actual Duration (Months)

Study Details

Study Description

Brief Summary

A pilot study of Dextran-40 infusion in patients with decompensated cirrhosis presenting with AKI

Condition or Disease Intervention/Treatment Phase
  • Drug: Dextran 40
 Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Focus on clinical response after receiving treatmentFocus on clinical response after receiving treatment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dextran, a Plasma Expander, Offers New Hope for Patients With Decompensated Liver Cirrhosis and Acute Kidney Injury
Actual Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Jun 30, 2016
Actual Study Completion Date :
Jun 30, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dextran 40

Dextran 40 infusion

Drug: Dextran 40
Dextran-40 infusion with the dose of 1 g/kg/day (10 ml/kg/day) for 2 days.
Other Names:
  • Colloidal plasma expander

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AKI reversal [2 weeks]

      Reducing creatinine to below 1.5 mg/dl

    Secondary Outcome Measures

    1. Mortality [1 year]

      Death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ramathibodi Hospital

    Investigators

    • Principal Investigator: Abhasnee Sobhonslidsuk, MD, Ramathibodi Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abhasnee Sobhonslidsuk, Associate professor, Ramathibodi Hospital
    ClinicalTrials.gov Identifier:
    NCT03070353
    Other Study ID Numbers:
    • ID 11-57-21
    First Posted:
    Mar 3, 2017
    Last Update Posted:
    Mar 3, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Abhasnee Sobhonslidsuk, Associate professor, Ramathibodi Hospital
    Cirrhosis
    AKI
    Albumin
    Dextran
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Acute Kidney Injury
    Fibrosis
    Dextrans

    Study Results

    No Results Posted as of Mar 3, 2017