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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03362632
• Other study ID #: SESLDIP study
• Status: Enrolling by invitation
• Start date: July 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: November 2017
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: June 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• End Stage Liver Disease
• Infection
• Liver Diseases
• Peritonitis
• Spontaneous Bacterial Peritonitis

Intervention

Drug:
• Antibiotics
This is an observation study, no specific antibiotics will be indicated during treatment.

Locations

Country	Name	City	State
China	Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate to empirical antibiotic treatment	The percentage of patients who achieved complete recovery from combined infection after empirical antibiotic treatment	6 months
Secondary	Non-liver transplant survival	Non-liver transplant survival rate at 30 days, 60 days and 6 months after empirical antibiotic treatment	6 months
Secondary	Hospitalization time	Days of hospitalization after empirical antibiotic treatment	6 months