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

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ClinicalTrials.gov Identifier: NCT03362632
Recruitment Status : Enrolling by invitation
First Posted : December 5, 2017
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Qin Ning, Tongji Hospital

Study Description
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Brief Summary:
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.

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

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIP Study)
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Infection Group
Patients with end stage liver disease with SBP
 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 SBP


Outcome Measures
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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


Eligibility Criteria
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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:

  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
Contacts and Locations
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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): NCT03362632


Locations
China, Hubei
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Tongji Hospital
More Information
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Responsible Party: Qin Ning, Director of Department of Infectious Disease, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03362632     History of Changes
Other Study ID Numbers: SESLDIP study
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: November 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
Intraabdominal Infections
Liver Diseases
Peritonitis
End Stage Liver Disease
Digestive System Diseases
 Peritoneal Diseases
Liver Failure
Hepatic Insufficiency
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents