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

Phase 2

Completed

• Conditions: Cirrhosis, Liver; AKI
• Interventions: Drug: Dextran 40

• Registration Number: NCT03070353
• Lead Sponsor: Ramathibodi Hospital

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.

Study Timeline

• Study Start: 2015-07-01
• Primary Completion: 2016-06-30
• Study Completion: 2016-06-30
• Status Verified: 2017-02
• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-02-28
• Last Update Submitted: 2017-02-28
• Study First Posted: 2017-03-03
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dextran 40	Dextran 40	Dextran 40 infusion

Primary Outcome Measures

Name	Time	Method
AKI reversal	2 weeks	Reducing creatinine to below 1.5 mg/dl

Secondary Outcome Measures

Name	Time	Method
Mortality	1 year	Death