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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

November 22, 2017
December 6, 2017
December 6, 2017
February 1, 2018
June 30, 2018   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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
  • Hospitalization time [ Time Frame: 6 months ]
    Days of hospitalization after empirical antibiotic treatment
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
Patients with chronic liver disease
  • End Stage Liver Disease
  • Infection
Drug: Antibiotics
This is an observation study, no specific antibiotics will be indicated during treatment
  • Infection Group
    Patients with end stage liver disease with infection
    Intervention: Drug: Antibiotics
  • Non-infection Group
    Patients with end stage liver disease without infection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
2000
Same as current
October 31, 2018
June 30, 2018   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
Child, Adult, Senior
No
China
 
 
NCT03363451
SESLDIR study
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Qin Ning, Tongji Hospital
Tongji Hospital
Not Provided
Not Provided
Tongji Hospital
December 2017