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

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

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.

Study Overview

• Status: Unknown
• Conditions: End Stage Liver Disease; Infection; Spontaneous Bacterial Peritonitis
• Intervention / Treatment: Drug: Antibiotics

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic liver disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-liver transplant survival	Non-liver transplant survival rate at 30 days, 60 days and 6 months after empirical antibiotic treatment	6 months
Hospitalization time	Days of hospitalization after empirical antibiotic treatment	6 months

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): September 13, 2018
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Peritoneal Diseases; Disease Attributes; Intraabdominal Infections; Liver Diseases; End Stage Liver Disease; Infections; Communicable Diseases; Peritonitis; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: SESLDIP study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No