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

NCT ID: NCT03363451

Last Updated: 2018-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2018-12-31

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.

Conditions

End Stage Liver Disease; Infection

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Infection Group

Patients with end stage liver disease with infection

Antibiotics

Intervention Type: DRUG

This is an observation study, no specific antibiotics will be indicated during treatment

Non-infection Group

Patients with end stage liver disease without infection

No interventions assigned to this group

Interventions

Antibiotics

This is an observation study, no specific antibiotics will be indicated during treatment

Intervention Type: DRUG

Eligibility Criteria

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

-

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Qin Ning

Director of Department of Infectious Disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Qin Ning, Prof.

Role: primary

qning@vip.sina.com

862883662391

Other Identifiers

SESLDIR study

Identifier Type: -

Identifier Source: org_study_id