Trial record 229 of 443 for:    hepatitis b | Open Studies

Prognosis Scoring System for Acute-on-Chronic Liver Failure

This study is not yet open for participant recruitment.
Verified September 2013 by Third Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Zhe-bin Wu, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01961440
First received: October 9, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

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.


Condition
Liver Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Further study details as provided by Third Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • survival rate [ Time Frame: twelve weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: October 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The population from large hospitals will be selected.

Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01961440

Contacts
Contact: zhe-bin wu 13751743264 wzbice1982@sohu.com

Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Zhe-bin Wu, Principal Investigator, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01961440     History of Changes
Other Study ID Numbers: zssywzb02
Study First Received: October 9, 2013
Last Updated: October 9, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Liver Failure
End Stage Liver Disease
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014