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

• Conditions: Infection; End Stage Liver Disease
• Interventions: Drug: Antibiotics

• Registration Number: NCT03363451
• Lead Sponsor: Tongji Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-22
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-06
• Study Start: 2018-02-01
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-14
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infection Group	Antibiotics	Patients with end stage liver disease with infection

Primary Outcome Measures

Name	Time	Method
Complete response rate to empirical antibiotic treatment	6 months	The percentage of patients who achieved complete recovery from combined infection after empirical antibiotic treatment

Secondary Outcome Measures

Name	Time	Method
Non-liver transplant survival	6 months	Non-liver transplant survival rate at 30 days, 60 days and 6 months after empirical antibiotic treatment
Hospitalization time	6 months	Days of hospitalization after empirical antibiotic treatment

Trial Locations

Locations (1)

Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China