Cirrhosis, LiverPhase 2/3NCT03070353
Dextran, a Plasma Expander, Offers New Hope for Patients With Decompensated Liver Cirrhosis and Acute Kidney Injury
A Phase 2/3 study testing Dextran 40 in people with Cirrhosis, Liver and AKI, run by Ramathibodi Hospital.
Trial summary
A pilot study of Dextran-40 infusion in patients with decompensated cirrhosis presenting with AKI Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cirrhosis, Liver, AKI
- What is being tested?
- Dextran 40
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 30 Jun 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Decompensated cirrhosis with acute kidney injury
- Ager over 18 years old
Who cannot join
- Having chronic kidney disease, severe heart or lung disease, severe sepsis
- Pregnant
- Receiving nephrotoxic agents
- Having history of allergic to Dextran
About this study
A pilot study of Dextran-40 infusion in patients with decompensated cirrhosis presenting with AKI
Read the 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.
- Conditions
- Cirrhosis, Liver, AKI
- Being tested
- Dextran 40
- Keywords
- Cirrhosis, AKI, Albumin, Dextran
- Medical subject headings
- Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextran 40Drug
Also called Colloidal plasma expander
Dextran-40 infusion with the dose of 1 g/kg/day (10 ml/kg/day) for 2 days.
| Study group | Role | What they receive |
|---|---|---|
| Dextran 40 | Experimental | Dextran 40 infusion Receives: Drug: Dextran 40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AKI reversal
Reducing creatinine to below 1.5 mg/dl
Measured: 2 weeks
Secondary outcomes (1)
Mortality
Death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Jul 2015
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Focus on clinical response after receiving treatment
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhasnee Sobhonslidsuk, Ramathibodi Hospital
- Investigators
- Abhasnee Sobhonslidsuk, MD, Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070353
- Sponsor's protocol ID
- ID 11-57-21
- Status last verified
- Feb 2017
- First submitted
- 28 Feb 2017
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be provided if directly contact with investigator
Publications
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.
PubMed 20953964
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dextran, a Plasma Expander, Offers New Hope for Patients With Decompensated Liver Cirrhosis and Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT03070353
- Acronym / sponsor ID
- ID 11-57-21
- Conditions
- Cirrhosis, Liver, AKI
- Keywords
- Cirrhosis, AKI, Albumin, Dextran
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Focus on clinical response after receiving treatment
| Arm | Type | Receives |
|---|---|---|
| Dextran 40 | Experimental | Drug: Dextran 40Dextran 40 infusion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Decompensated cirrhosis with acute kidney injury
- Ager over 18 years old
Key exclusion criteria (4 listed)
- Having chronic kidney disease, severe heart or lung disease, severe sepsis
- Pregnant
- Receiving nephrotoxic agents
- Having history of allergic to Dextran
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextran 40Also: Colloidal plasma expanderDextran-40 infusion with the dose of 1 g/kg/day (10 ml/kg/day) for 2 days. | Drug | Dextran 40 |
Primary outcome
AKI reversal
Time frame: 2 weeks
Reducing creatinine to below 1.5 mg/dl
1 secondary outcome
Mortality
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Results publication: PubMed 20953964Niemi 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.
- Individual participant dataSharing planned: No. IPD will be provided if directly contact with investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abhasnee Sobhonslidsuk, MD principal investigator
Ramathibodi Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dextran 40 in people with Cirrhosis, Liver and AKI, run by Ramathibodi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AKI reversal (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03070353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.