End Stage Liver DiseaseNCT03363451
A Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIR Study)
An observational study of End Stage Liver Disease and Infection, run by Tongji Hospital at 1 site in China.
Trial summary
The term of End Stage of Liver Disease (ESLD) was raised in 80's of 20 Century, but without a restrict definition. Infections are the cause and effect in occurrence and development of ESLD, which not only induce or exacerbate ESLD, but also are the most combined complication. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Liver Disease, Infection
- What is being tested?
- Antibiotics
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 31 Dec 2018
- 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
- Decompensation of liver cirrhosis:
- ALB <35 g / L; A / G <1.0
- TBIL> 35μmol / L;
- ALT> 1 × ULN and / or AST> 1 × ULN
- PTA <60%
- Ascites or hepatic encephalopathy or esophageal variceal bleeding
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- Acute-on-chronic liver failure:
- Chronic liver disease based on: chronic hepatitis or decompensated cirrhosis
- onset time: <4 weeks
- Hepatic encephalopathy: with or without
- Coagulation: PTA ≤ 40% or INR ≥ 1.5
- Jaundice: TBIL ≥ 171μmol / L or daily increase ≥ 17.1μmol / L
- Chronic liver failure:
- The basis of chronic liver disease: decompensated cirrhosis
- onset time: -
- Hepatic encephalopathy: with or without
- Coagulation: PTA ≤ 40% or INR ≥ 1.5 Jaundice: significantly higher
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Qin Ning, Prof., 862883662391, qning@vip.sina.com
About this study
Official title: A Retrospective Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIR Study)
The term of End Stage of Liver Disease (ESLD) was raised in 80's of 20 Century, but without a restrict definition. Infections are the cause and effect in occurrence and development of ESLD, which not only induce or exacerbate ESLD, but also are the most combined complication. Multi-resistant bacteria, multi-organ injury, selection of anti-microbes, supporting treatment, disorder of intestine microbiota, et al are dilemma in clinical practice. Appropriate and formal diagnosis and treatment of ESLD combined infection are imperious nowadays.
- Conditions
- End Stage Liver Disease, Infection
- 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 infection Receives: Drug: Antibiotics | |
| Non-infection Group | Patients with end stage liver disease without infection |
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 posted6 Dec 2017
- Study start1 Feb 2018
- Primary completion30 Dec 2018 (estimated)
- Study completion31 Dec 2018 (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
- Retrospective
- Enrolment
- 2,000 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
- NCT03363451
- Sponsor's protocol ID
- SESLDIR study
- Status last verified
- Dec 2017
- First submitted
- 22 Nov 2017
- Last updated
- 14 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 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIR Study)
- ClinicalTrials.gov ID
- NCT03363451
- Acronym / sponsor ID
- SESLDIR study
- Conditions
- End Stage Liver Disease, Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 6 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.
The term of End Stage of Liver Disease (ESLD) was raised in 80's of 20 Century, but without a restrict definition. Infections are the cause and effect in occurrence and development of ESLD, which not only induce or exacerbate ESLD, but also are the most combined complication. Multi-resistant bacteria, multi-organ injury, selection of anti-microbes, supporting treatment, disorder of intestine microbiota, et al are dilemma in clinical practice. Appropriate and formal diagnosis and treatment of ESLD combined infection are imperious nowadays.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infection Group | – | Drug: AntibioticsPatients with end stage liver disease with infection |
| Non-infection Group | – | –Patients with end stage liver disease without infection |
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 (17 listed)
- ALB <35 g / L; A / G <1.0
- TBIL> 35μmol / L;
- ALT> 1 × ULN and / or AST> 1 × ULN
- PTA <60%
- Ascites or hepatic encephalopathy or esophageal variceal bleeding
Key exclusion criteria (1 listed)
- -
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 14 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.
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
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 17 inclusion and 1 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 14 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 14 Sep 2018.