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OpenTrials
Completed

NCT Number: NCT03070353

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

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

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Key information

Conditions

Cirrhosis, Liver AKI Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dextran 40

Drug

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

Other names: Colloidal plasma expander

Primary outcomes

  1. AKI reversal

    Time frame: 2 weeks

    Reducing creatinine to below 1.5 mg/dl

Secondary outcomes

  1. Mortality

    Time frame: 1 year

    Death

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 3, 2017
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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