Prognosis Scoring System for Acute-on-Chronic Liver Failure

Liver Failure Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01961440
• Other study ID #: zssywzb02
• Status: Not yet recruiting
• Phase: N/A
• First received: October 9, 2013
• Last updated: October 9, 2013
• Start date: October 2013

Study information

• Verified date: September 2013
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: zhe-bin wu
• Phone: 13751743264
• Email: wzbice1982[@]sohu.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical 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， 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Failure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rate		twelve weeks	No