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

NCT ID: NCT03070353

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-01

Study Completion Date

2016-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cirrhosis, Liver AKI

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Focus on clinical response after receiving treatment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dextran 40

Dextran 40 infusion

Group Type EXPERIMENTAL

Dextran 40

Intervention Type DRUG

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

Interventions

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Dextran 40

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

Intervention Type DRUG

Other Intervention Names

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Colloidal plasma expander

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ramathibodi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Abhasnee Sobhonslidsuk

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abhasnee Sobhonslidsuk, MD

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital

References

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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.

Reference Type RESULT
PMID: 20953964 (View on PubMed)

Other Identifiers

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ID 11-57-21

Identifier Type: -

Identifier Source: org_study_id

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