Liver FailureNCT00772252
Oxidative Stress and Microcirculation in Patient With Hepatic Failure Undergoing Liver Support Treatment
An observational study of Liver Failure and Critical Care, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background: In patients undergoing hemodialysis or hemofiltration will suffer from the injury of reactive oxidative species. Oxidative stress will affect cell membrane, protein, and DNA. It will damage the cell and result in organ dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Failure, Critical Care
- What is being tested?
- liver support treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2008to Dec 2010
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients require liver support treatment
Who may be able to join
- Age > 18 years old
- Patients with acute deterioration on Chronic liver failure, who required liver support treamtment
- Patients with acute liver failure due to acute hepatitis, who reauired liver support treatment
- Patients with acute liver dysfunction within 7 days after liver transplantation, who required liver support treatment
Who cannot join
- Age > 70 years old
- Cancer, not curable
- Patients who had used of antioxidant therapy within 24 hours before study
- Patients who had received hyperbaric oxygen therapy within 24 hours before study
- Patients who had received peroxide treatment within 24 hours before study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Yu-Chang Yeh, bachelor, 886-9-68661829, tonyyeh@ntuh.gov.tw
Yu-Chang Yeh, Bachelor
About this study
Background: In patients undergoing hemodialysis or hemofiltration will suffer from the injury of reactive oxidative species. Oxidative stress will affect cell membrane, protein, and DNA. It will damage the cell and result in organ dysfunction. We believe that in patients, who have acute hepatic failure, undergoing plasma exchange or Molecular Absorbent Recirculating System for bridge therapy will suffer from the injury of reactive oxidative species, too. It will damage the kidney, lung, cerebral cortex, and other organs. It may result in death before the recovery of liver function or undergoing liver transplantation.
Aims: 1. Investigate the severity of oxidative stress and risk factors of high oxidative stress in acute hepatic failure patient undergoing plasma exchange or Molecular Absorbent Recirculating System. 2. Investigate the microcirculation status and risk factors in acute hepatic failure patient undergoing plasma exchange or Molecular Absorbent Recirculating System. 3. Study the relationship between oxidative stress and microcirculation status. 4. Study the correlation between oxidative stress and prognosis. 5. Study the correlation between microcirculation status and prognosis.
- Conditions
- Liver Failure, Critical Care
- Being tested
- liver support treatment
- Keywords
- Liver support treatment
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver support treatmentOther
plasma exchange for liver support treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | patient with hepatic failure undergoing liver support treatment in surgical intensive care unit Receives: Other: liver support treatment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yu-Chang Yeh, Bacehlor, Study director, Department of Anesthesiology, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772252
- Sponsor's protocol ID
- 200806004R
- Status last verified
- Jun 2010
- First submitted
- 14 Oct 2008
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress and Microcirculation in Patient With Hepatic Failure Undergoing Liver Support Treatment
- ClinicalTrials.gov ID
- NCT00772252
- Acronym / sponsor ID
- 200806004R
- Conditions
- Liver Failure, Critical Care
- Keywords
- Liver support treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 15 Oct 2008 (estimated)
- 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.
Background: In patients undergoing hemodialysis or hemofiltration will suffer from the injury of reactive oxidative species. Oxidative stress will affect cell membrane, protein, and DNA. It will damage the cell and result in organ dysfunction. We believe that in patients, who have acute hepatic failure, undergoing plasma exchange or Molecular Absorbent Recirculating System for bridge therapy will suffer from the injury of reactive oxidative species, too. It will damage the kidney, lung, cerebral cortex, and other organs. It may result in death before the recovery of liver function or undergoing liver transplantation.
Aims: 1. Investigate the severity of oxidative stress and risk factors of high oxidative stress in acute hepatic failure patient undergoing plasma exchange or Molecular Absorbent Recirculating System. 2. Investigate the microcirculation status and risk factors in acute hepatic failure patient undergoing plasma exchange or Molecular Absorbent Recirculating System. 3. Study the relationship between oxidative stress and microcirculation status. 4. Study the correlation between oxidative stress and prognosis. 5. Study the correlation between microcirculation status and prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: liver support treatmentpatient with hepatic failure undergoing liver support treatment in surgical intensive care unit |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients require liver support treatment
Key inclusion criteria (4 listed)
- Age > 18 years old
- Patients with acute deterioration on Chronic liver failure, who required liver support treamtment
- Patients with acute liver failure due to acute hepatitis, who reauired liver support treatment
- Patients with acute liver dysfunction within 7 days after liver transplantation, who required liver support treatment
Key exclusion criteria (5 listed)
- Age > 70 years old
- Cancer, not curable
- Patients who had used of antioxidant therapy within 24 hours before study
- Patients who had received hyperbaric oxygen therapy within 24 hours before study
- Patients who had received peroxide treatment within 24 hours before study
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 |
|---|---|---|
| liver support treatmentplasma exchange for liver support treatment | Other | 1 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
Related trials for Liver Failure
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Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
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LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
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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.
Yu-Chang Yeh, Bacehlor study director
Department of Anesthesiology, NTUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Failure and Critical Care, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Chang Yeh (0968661829, tonyyeh@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 29 Jun 2010.