Liver FailureNCT01961440
Prognosis Scoring System for Acute-on-Chronic Liver Failure
An observational study of Liver Failure, run by Third Affiliated Hospital, Sun Yat-Sen University.
Trial summary
This research is to establish a simple and practical system to predict the prognosis of sever hepatitis B.Seven factors (level of serum total bilirubin, prothrombin time, severity of hepatic encephalopathy, hepatorenal syndrome,ascites ,infection and size of liver) which were easier to evaluate and more influential，… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Failure
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Dec 2014
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The population from large hospitals will be selected.
Who may be able to join
- serum hepatitis B surface antigen(HBsAg) positive for at least 6 months;
- All patients had a poor general condition, manifested as general malaise, fatigue, jaundice and so on;
- serum T-Bil of 171 mmol/L or more; or serum T-Bil rises 17.1 mmol/L or more per day;
Who cannot join
- superinfection or co-infection with hepatitis A, C, D, E, cytomegalovirus and HIV, or Epstein-Barr virus;
- other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis;
- ascites or gastrointestinal bleeding or peptic ulcer or esophageal varix by electronic gastroscope examination;
- decompensated liver cirrhosis;
- severe bacterial or fungal infections;
- a history of diabetes or cardiac disease or hypertension or nephrosis.
Trial locations and contacts
No sites are listed yet.
About this study
This research is to establish a simple and practical system to predict the prognosis of sever hepatitis B.Seven factors (level of serum total bilirubin, prothrombin time, severity of hepatic encephalopathy, hepatorenal syndrome,ascites ,infection and size of liver) which were easier to evaluate and more influential， were included to establish a prognosis scoring system．The scorings of a new score system and MELD were graded at the same time in the patients with sever hepatitis B. And then the distribution figures of survival rates and mortality rates were done according to the scores from low to high. The features of distribution figures of two score system in survival rates and mortality rates and significances of clinical application in certain score were interpreted.
- Conditions
- Liver Failure
- Medical subject headings
- Liver Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
Measured: twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014 (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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhe-bin Wu, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961440
- Sponsor's protocol ID
- zssywzb02
- Status last verified
- Sep 2013
- First submitted
- 9 Oct 2013
- Last updated
- 11 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Scoring System for Acute-on-Chronic Liver Failure
- ClinicalTrials.gov ID
- NCT01961440
- Acronym / sponsor ID
- zssywzb02
- Conditions
- Liver Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 11 Oct 2013 (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.
This research is to establish a simple and practical system to predict the prognosis of sever hepatitis B.Seven factors (level of serum total bilirubin, prothrombin time, severity of hepatic encephalopathy, hepatorenal syndrome,ascites ,infection and size of liver) which were easier to evaluate and more influential， were included to establish a prognosis scoring system．The scorings of a new score system and MELD were graded at the same time in the patients with sever hepatitis B. And then the distribution figures of survival rates and mortality rates were done according to the scores from low to high. The features of distribution figures of two score system in survival rates and mortality rates and significances of clinical application in certain score were interpreted.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The population from large hospitals will be selected.
Key inclusion criteria (3 listed)
- serum hepatitis B surface antigen(HBsAg) positive for at least 6 months;
- All patients had a poor general condition, manifested as general malaise, fatigue, jaundice and so on;
- serum T-Bil of 171 mmol/L or more; or serum T-Bil rises 17.1 mmol/L or more per day;
Key exclusion criteria (6 listed)
- superinfection or co-infection with hepatitis A, C, D, E, cytomegalovirus and HIV, or Epstein-Barr virus;
- other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis;
- ascites or gastrointestinal bleeding or peptic ulcer or esophageal varix by electronic gastroscope examination;
- decompensated liver cirrhosis;
- severe bacterial or fungal infections;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
survival rate
Time frame: twelve weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2013.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Failure, run by Third Affiliated Hospital, Sun Yat-Sen University.
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 3 inclusion and 6 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 11 Oct 2013. 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.
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 zhe-bin wu (13751743264, wzbice1982@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate (time frame: twelve weeks). It is what the study was designed to measure, not a finding.
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 11 Oct 2013.