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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)
Estimated Study Start Date :	January 1, 2018
Estimated Primary Completion Date :	December 31, 2018
Estimated Study Completion Date :	June 30, 2019

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Last Update Posted:	December 5, 2017
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; Liver Diseases; Peritonitis; End Stage Liver Disease; Digestive System Diseases; Intraabdominal Infections	Peritoneal Diseases; Liver Failure; Hepatic Insufficiency; Anti-Bacterial Agents; Antibiotics, Antitubercular; Anti-Infective Agents; Antitubercular Agents