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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03070353
Other study ID # ID 11-57-21
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received February 28, 2017
Last updated February 28, 2017
Start date July 1, 2015
Est. completion date June 30, 2016

Study information

Verified date February 2017
Source Ramathibodi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date June 30, 2016
Est. primary completion date June 30, 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ramathibodi Hospital

References & 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary AKI reversal Reducing creatinine to below 1.5 mg/dl 2 weeks
Secondary Mortality Death 1 year
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