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

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ClinicalTrials.gov Identifier: NCT03363451
Recruitment Status : Not yet recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Qin Ning, 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.

Condition or disease Intervention/treatment
End Stage Liver Disease Infection Drug: Antibiotics

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Retrospective Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIR Study)
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Complete response rate to empirical antibiotic treatment [ Time Frame: 6 months ]
    The percentage of patients who achieved complete recovery from combined infection after empirical antibiotic treatment


Secondary Outcome Measures :
  1. Non-liver transplant survival [ Time Frame: 6 months ]
    Non-liver transplant survival rate at 30 days, 60 days and 6 months after empirical antibiotic treatment

  2. Hospitalization time [ Time Frame: 6 months ]
    Days of hospitalization after empirical antibiotic treatment



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic liver disease
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363451


Locations
China, Hubei
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Enrolling by invitation
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Tongji Hospital

Responsible Party: Qin Ning, Director of Department of Infectious Disease, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03363451     History of Changes
Other Study ID Numbers: SESLDIR study
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Liver Diseases
End Stage Liver Disease
Digestive System Diseases
Liver Failure
Hepatic Insufficiency
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents