End Stage Liver DiseaseNCT03362632
A Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIP Study)
An observational study of End Stage Liver Disease and Infection, run by Tongji Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Liver Disease, Infection, Spontaneous Bacterial Peritonitis
- What is being tested?
- Antibiotics
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic liver disease
Who may be able to join
- 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
Who cannot join
- history of abdominal surgery within 4 weeks;
- secondary peritonitis;
- tuberculous peritonitis;
- Malignant tumor;
- patients who use hormones or immunosuppressants;
- AIDS patients;
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: 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.
- Being tested
- Antibiotics
- Medical subject headings
- End Stage Liver Disease, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsDrug
This is an observation study, no specific antibiotics will be indicated during treatment.
| Study group | Role | What they receive |
|---|---|---|
| Infection Group | Patients with end stage liver disease with SBP Receives: Drug: Antibiotics | |
| Non-infection Group | Patients with end stage liver disease without SBP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate to empirical antibiotic treatment
The percentage of patients who achieved complete recovery from combined infection after empirical antibiotic treatment
Measured: 6 months
Secondary outcomes (2)
Non-liver transplant survival
Non-liver transplant survival rate at 30 days, 60 days and 6 months after empirical antibiotic treatment
Measured: 6 months
Hospitalization time
Days of hospitalization after empirical antibiotic treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Jul 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Ning, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362632
- Sponsor's protocol ID
- SESLDIP study
- Status last verified
- Nov 2017
- First submitted
- 22 Nov 2017
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIP Study)
- ClinicalTrials.gov ID
- NCT03362632
- Acronym / sponsor ID
- SESLDIP study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infection Group | – | Drug: AntibioticsPatients with end stage liver disease with SBP |
| Non-infection Group | – | –Patients with end stage liver disease without SBP |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic liver disease
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- history of abdominal surgery within 4 weeks;
- secondary peritonitis;
- tuberculous peritonitis;
- Malignant tumor;
- patients who use hormones or immunosuppressants;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticsThis is an observation study, no specific antibiotics will be indicated during treatment. | Drug | Infection Group |
Primary outcome
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
2 secondary outcomes
Non-liver transplant survival
Time frame: 6 months
Hospitalization time
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Liver Disease and Infection, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate to empirical antibiotic treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.