A Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIP Study)
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ClinicalTrials.gov Identifier: NCT03362632 |
Recruitment Status
:
Enrolling by invitation
First Posted
: December 5, 2017
Last Update Posted
: December 5, 2017
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Condition or disease | Intervention/treatment |
---|---|
End Stage Liver Disease Infection Spontaneous Bacterial Peritonitis | Drug: Antibiotics |
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 |
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
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- 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
- 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
- Hospitalization time [ Time Frame: 6 months ]Days of hospitalization after empirical antibiotic treatment

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362632
China, Hubei | |
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | |
Wuhan, Hubei, China, 430030 |
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 Key Record Dates |
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 |