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

NCT03363451 | Unknown

• 1 other identifier: SESLDIR study
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Non-liver transplant survival

  6 months

• Hospitalization time

  6 months

Study Arms (2)

Infection Group

Patients with end stage liver disease with infection

Drug: Antibiotics

Non-infection Group

Patients with end stage liver disease without infection

Interventions

Antibiotics DRUG

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

Infection Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic liver disease

You may qualify if:

• Decompensation of liver cirrhosis:
• ALB \<35 g / L; A / G \<1.0
• TBIL\> 35μmol / L;
• ALT\> 1 × ULN and / or AST\> 1 × ULN
• PTA \<60%
• Ascites or hepatic encephalopathy or esophageal variceal bleeding
• Acute-on-chronic liver failure:
• Chronic liver disease based on: chronic hepatitis or decompensated cirrhosis
• onset time: \<4 weeks
• Hepatic encephalopathy: with or without
• Coagulation: PTA ≤ 40% or INR ≥ 1.5
• Jaundice: TBIL ≥ 171μmol / L or daily increase ≥ 17.1μmol / L
• Chronic liver failure:
• The basis of chronic liver disease: decompensated cirrhosis
• onset time: -

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

End Stage Liver Disease; Infections

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Infectious Disease

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 6, 2017
• Study Start: February 1, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 31, 2018
• Last Updated: September 14, 2018

Record last verified: 2017-12

Locations

CN (1)