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

February 28, 2017 updated by: Abhasnee Sobhonslidsuk, Ramathibodi Hospital
A pilot study of Dextran-40 infusion in patients with decompensated cirrhosis presenting with AKI

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AKI reversal
Time Frame: 2 weeks
Reducing creatinine to below 1.5 mg/dl
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 1 year
Death
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramathibodi Hospital

Investigators

  • Principal Investigator: Abhasnee Sobhonslidsuk, MD, Ramathibodi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

June 30, 2016

Study Completion (Actual)

June 30, 2016

Study Registration Dates

First Submitted

February 28, 2017

First Submitted That Met QC Criteria

February 28, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID 11-57-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD will be provided if directly contact with investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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