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

NCT03362632 | Unknown

• 1 other identifier: SESLDIP study
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Liver Disease; Infection; Spontaneous Bacterial Peritonitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Non-liver transplant survival

  6 months

• Hospitalization time

  6 months

Study Arms (2)

Infection Group

Patients with end stage liver disease with SBP

Drug: Antibiotics

Non-infection Group

Patients with end stage liver disease without SBP

Interventions

Antibiotics DRUG

This is an observation study, no specific antibiotics will be indicated during treatment.

Infection Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic liver disease

You may qualify if:

• Meet the end-stage liver disease part of the type of standard (including slow plus acute liver failure, chronic liver failure, cirrhosis decompensation);
• age\> 18 years old
• ascites nucleated cell count\> 250 × 106 / L;
• 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

You may not qualify if:

• history of abdominal surgery within 4 weeks;
• secondary peritonitis;
• tuberculous peritonitis;
• Malignant tumor;
• patients who use hormones or immunosuppressants;
• AIDS patients;
• heart failure or respiratory failure;
• merge other parts of the infection;
• died within 48h;
• liver transplantation during observation;
• Diagnosis of spontaneous bacterial peritonitis is the use of carbapenems or third-generation cephalosporins / enzyme inhibitors, piperacillin / enzyme inhibitor antibiotics

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

End Stage Liver Disease; Infections

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Infectious Disease

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 5, 2017
• Study Start: July 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: June 30, 2019
• Last Updated: September 13, 2018

Record last verified: 2017-11

Locations

CN (1)