A Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIR Study)

Infection Clinical Trial

Official title:

A Retrospective Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIR Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03363451
• Other study ID #: SESLDIR study
• Status: Recruiting
• Start date: February 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: December 2017
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The term of End Stage of Liver Disease (ESLD) was raised in 80's of 20 Century, but without a restrict definition. Infections are the cause and effect in occurrence and development of ESLD, which not only induce or exacerbate ESLD, but also are the most combined complication. Multi-resistant bacteria, multi-organ injury, selection of anti-microbes, supporting treatment, disorder of intestine microbiota, et al are dilemma in clinical practice. Appropriate and formal diagnosis and treatment of ESLD combined infection are imperious nowadays.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Decompensation of liver cirrhosis:

1. ALB <35 g / L; A / G <1.0

2. TBIL> 35µmol / L;

3. ALT> 1 × ULN and / or AST> 1 × ULN

4. PTA <60%

5. Ascites or hepatic encephalopathy or esophageal variceal bleeding

Acute-on-chronic liver failure:

1. Chronic liver disease based on: chronic hepatitis or decompensated cirrhosis

2. onset time: <4 weeks

3. Hepatic encephalopathy: with or without

4. Coagulation: PTA = 40% or INR = 1.5

5. Jaundice: TBIL = 171µmol / L or daily increase = 17.1µmol / L

Chronic liver failure:

1. The basis of chronic liver disease: decompensated cirrhosis

2. onset time: -

3. Hepatic encephalopathy: with or without

4. Coagulation: PTA = 40% or INR = 1.5 Jaundice: significantly higher

Exclusion Criteria:

Related Conditions & MeSH terms

• Communicable Diseases
• End Stage Liver Disease
• Infection
• Liver Diseases

Intervention

Drug:
• Antibiotics
This is an observation study, no specific antibiotics will be indicated during treatment

Locations

Country	Name	City	State
China	Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate to empirical antibiotic treatment	The percentage of patients who achieved complete recovery from combined infection after empirical antibiotic treatment	6 months
Secondary	Non-liver transplant survival	Non-liver transplant survival rate at 30 days, 60 days and 6 months after empirical antibiotic treatment	6 months
Secondary	Hospitalization time	Days of hospitalization after empirical antibiotic treatment	6 months