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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00772252
Other study ID # 200806004R
Secondary ID
Status Recruiting
Phase N/A
First received October 14, 2008
Last updated June 28, 2010
Start date August 2008
Est. completion date December 2010

Study information

Verified date June 2010
Source National Taiwan University Hospital
Contact Yu-Chang Yeh
Phone 0968661829
Email tonyyeh@ntuh.gov.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Age > 18 years old

2. Patients with acute deterioration on Chronic liver failure, who required liver support treamtment

3. Patients with acute liver failure due to acute hepatitis, who reauired liver support treatment

4. Patients with acute liver dysfunction within 7 days after liver transplantation, who required liver support treatment

Exclusion Criteria:

1. Age > 70 years old

2. Cancer, not curable

3. Patients who had used of antioxidant therapy within 24 hours before study

4. Patients who had received hyperbaric oxygen therapy within 24 hours before study

5. Patients who had received peroxide treatment within 24 hours before study

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
liver support treatment
plasma exchange for liver support treatment

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

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