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)

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.

Study Overview

• Status: Unknown
• Conditions: End Stage Liver Disease; Infection
• Intervention / Treatment: Drug: Antibiotics

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Qin Ning, Prof.; Phone Number: 862883662391; Email: qning@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic liver disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infection Group; Patients with end stage liver disease with infection	Drug: Antibiotics; This is an observation study, no specific antibiotics will be indicated during treatment
Non-infection Group; Patients with end stage liver disease without infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Anticipated): December 30, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Disease Attributes; Liver Diseases; End Stage Liver Disease; Infections; Communicable Diseases; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: SESLDIR study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No