ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03362632
Recruitment Status : Enrolling by invitation
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Qin Ning, Tongji Hospital

November 22, 2017
December 5, 2017
December 5, 2017
January 1, 2018
December 31, 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 (SESLDIP Study)
A Prospective Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIP Study)
Spontaneous bacterial peritonitis (SBP) is a common complication of end-stage liver disease due to various causes. The initial anti-infective medication is appropriate and the patient's survival rate is closely related. Ascitic fluid bacterial culture takes a long time, the positive rate is low, it is difficult to guide the timely use of antimicrobial drugs, empirical medicine based on evidence-based medicine for SBP in patients with end-stage liver disease is essential. The American College of Hepatology and the European Society of Hepatology recommend the use of third-generation cephalosporins as the first choice of empirical therapy in patients with end-stage liver disease associated with community-acquired SBP. Patients with merger of hospital-acquired SBP with piperacillin / tazobactam or carbapenem +/- glycopeptide antibiotics is the first choice for empirical medication. There is no clear recommendation in China. In recent years, the conclusions of international clinical research in this area have been in disagreement with the recommendations. As a key factor in the selection of empirical antibiotics is local bacterial resistance data, these findings are difficult to evidence-based medicine for Chinese doctors. This project intends to observe the efficacy of different initial anti-infective regimens in Chinese patients with end-stage liver disease with SBP and 30-day and 60-day non-liver transplant survival rates, providing evidence-based medical evidence for the empirical use of such patients.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with chronic liver disease
  • End Stage Liver Disease
  • Infection
  • Spontaneous Bacterial Peritonitis
Drug: Antibiotics
This is an observation study, no specific antibiotics will be indicated during treatment.
  • Infection Group
    Patients with end stage liver disease with SBP
    Intervention: Drug: Antibiotics
  • Non-infection Group
    Patients with end stage liver disease without SBP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
400
Same as current
June 30, 2019
December 31, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Meet the end-stage liver disease part of the type of standard (including slow plus acute liver failure, chronic liver failure, cirrhosis decompensation);
  2. age> 18 years old
  3. ascites nucleated cell count> 250 × 106 / L;
  4. Unable to obtain ascites specimens or ascites nucleated cells count does not meet the conditions of 3) are required abdominal examination tenderness (+), rebound tenderness (+), abdominal ultrasound can detect ascites, and procalcitonin (PCT) > 0.5ng / ml, hs-CRP> 10ng / ml

Exclusion Criteria:

  1. history of abdominal surgery within 4 weeks;
  2. secondary peritonitis;
  3. tuberculous peritonitis;
  4. Malignant tumor;
  5. patients who use hormones or immunosuppressants;
  6. AIDS patients;
  7. heart failure or respiratory failure;
  8. merge other parts of the infection;
  9. died within 48h;
  10. liver transplantation during observation;
  11. Diagnosis of spontaneous bacterial peritonitis is the use of carbapenems or third-generation cephalosporins / enzyme inhibitors, piperacillin / enzyme inhibitor antibiotics
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT03362632
SESLDIP 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
November 2017