Dextran, a Plasma Expander, Offers New Hope for Patients... | NCT03070353

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

NCT03070353

Sponsor

Ramathibodi Hospital

Status

Completed

Last Update Posted

Mar 3, 2017Actual

Enrollment

10Actual

Phase

Phase 2Phase 3

Conditions

Cirrhosis, Liver
AKI

Interventions

Dextran 40

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2015Actual

Primary Completion Date

Jun 30, 2016Actual

Completion Date

Jun 30, 2016Actual

First Submitted Date

Feb 28, 2017

First Submission Date that Met QC Criteria

Feb 28, 2017

First Posted Date

Mar 3, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2017

Last Update Posted Date

Mar 3, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dextran 40	Experimental	Dextran 40 infusion	Drug: Dextran 40

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dextran 40	Drug	Dextran-40 infusion with the dose of 1 g/kg/day (10 ml/kg/day) for 2 days.	Dextran 40

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Mortality	Death	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abhasnee Sobhonslidsuk, MD	Ramathibodi Hospital	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20953964	Result	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.

ID	Term
D008103	Liver Cirrhosis
D005355	Fibrosis

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D005936	Glucans
D001704	Biopolymers
D011108	Polymers
D046911	Macromolecular Substances