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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03363451
Enrollment
2000
Registered
2017-12-06
Start date
2018-02-01
Completion date
2018-12-31
Last updated
2018-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Liver Disease, Infection

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.

Interventions

DRUGAntibiotics

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

Sponsors

Tongji Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Complete response rate to empirical antibiotic treatment6 monthsThe percentage of patients who achieved complete recovery from combined infection after empirical antibiotic treatment

Secondary

MeasureTime frameDescription
Non-liver transplant survival6 monthsNon-liver transplant survival rate at 30 days, 60 days and 6 months after empirical antibiotic treatment
Hospitalization time6 monthsDays of hospitalization after empirical antibiotic treatment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026