Clinical trial NCT03362632: A Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIP Study)
Official title: A Prospective Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIP Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Liver Disease
Infection
Spontaneous Bacterial Peritonitis
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic liver disease

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.


Eligibility 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

Primary outcomes:
measure: Complete response rate to empirical antibiotic treatment
timeFrame: 6 months
Secondary outcomes:
measure: Non-liver transplant survival
timeFrame: 6 months
measure: Hospitalization time
timeFrame: 6 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: