NCT03070353

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

February 28, 2017

Last Update Submit

February 28, 2017

Conditions

Cirrhosis, LiverAKI

Keywords

CirrhosisAKIAlbuminDextran

Outcome Measures

Primary Outcomes (1)

  • AKI reversal

    Reducing creatinine to below 1.5 mg/dl

    2 weeks

Secondary Outcomes (1)

  • Mortality

    1 year

Study Arms (1)

Dextran 40

EXPERIMENTAL

Dextran 40 infusion

Drug: Dextran 40

Interventions

Dextran 40DRUG

Dextran-40 infusion with the dose of 1 g/kg/day (10 ml/kg/day) for 2 days.

Also known as: Colloidal plasma expander
Dextran 40

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20953964RESULT

MeSH Terms

Conditions

Liver CirrhosisFibrosis

Interventions

Dextrans

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydrates

Study Officials

  • Abhasnee Sobhonslidsuk, MD

    Ramathibodi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Focus on clinical response after receiving treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 3, 2017

Study Start

July 1, 2015

Primary Completion

June 30, 2016

Study Completion

June 30, 2016

Last Updated

March 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

IPD will be provided if directly contact with investigator