Cirrhosis, LiverNCT03204591
Bacterial Infections in Cirrhotic Patients With Acute Severe Liver Injury
An observational study of Cirrhosis, Liver and Bacterial Infections, run by The Zhejiang Study Group for Organ Failure in Cirrhosis at 1 site in China.
Trial summary
Acute hepatic insults including hepatitis flare-up, active alcohol assumption and hepatotoxic drug use are common in patients with cirrhosis especially in Eastern countries.These patients are at high risk of developing acute-on-chronic liver failure (ACLF) and associated with high short-term mortality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cirrhosis, Liver, Bacterial Infections, Acute Liver Injury
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2017to 18 Jan 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 cirrhosis of any etiology who had acute severe liver injury
Who may be able to join
- The presence of cirrhosis confirmed by liver biopsy, endoscopy, radiological examination, or clinical evidence of prior hepatic de-compensation;
- Flare up of acute severe liver injury within one month before enrollment. Acute severe liver injury is defined as: increase of serum bilirubin >=85mmol/L and international normalized ratio (INR)>=1.5 with a definite hepatic insult.
Who cannot join
- (1)pregnancy; (2) disseminated maliganancy; (3)previously received a liver transplant; (4) HIV infection;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310009
Hong Zhao, MD
Yu Shi, MD
About this study
Official title: Risk of Bacterial Infection in Cirrhotic Patients With Acute Severe Liver Injury: a Multicenter,Prospective, Observational Study
Acute hepatic insults including hepatitis flare-up, active alcohol assumption and hepatotoxic drug use are common in patients with cirrhosis especially in Eastern countries.These patients are at high risk of developing acute-on-chronic liver failure (ACLF) and associated with high short-term mortality. And the natural history of these patients is frequently complicated by bacterial infections, which lead to deterioration of underlying diseases. The present study is aimed to investigate the prevalance and risk factors of bacterial infections in those patients and its impact on in-hospital/short-term mortality.
- Conditions
- Cirrhosis, Liver, Bacterial Infections, Acute Liver Injury
- Being tested
- No intervention
- Medical subject headings
- Liver Cirrhosis, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| LC with SALI | cirrhosis patients with severe acute liver injury Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of bacterial infection
Site,source, pathogen and severity
Measured: Within 3 months from admission
Secondary outcomes (2)
28-day Mortality
Disease-associated mortality
Measured: Within 28 days after enrollment
90-day Mortality
Disease-associated mortality
Measured: Within 90 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start20 Jul 2017
- Primary completion18 Oct 2018 (estimated)
- Study completion18 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Zhejiang Study Group for Organ Failure in Cirrhosis
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo No.2 Hospital
- Responsible party
- Principal investigator, Shi Yu, The Zhejiang Study Group for Organ Failure in Cirrhosis
- Investigators
- Jifang Sheng, Doctor, Study chair, Department of infectious disease, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204591
- Sponsor's protocol ID
- NSFC81670567
- Status last verified
- Jun 2018
- First submitted
- 27 Jun 2017
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Bacterial Infection in Cirrhotic Patients With Acute Severe Liver Injury: a Multicenter,Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT03204591
- Acronym / sponsor ID
- NSFC81670567
- Conditions
- Cirrhosis, Liver, Bacterial Infections, Acute Liver Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Zhejiang Study Group for Organ Failure in CirrhosisUniversity, hospital or other
- Collaborators
- Ningbo No.2 Hospital
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 18 Oct 2018 (estimated)
- Study completion
- 18 Jan 2019 (estimated)
- First posted
- 2 Jul 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.
Acute hepatic insults including hepatitis flare-up, active alcohol assumption and hepatotoxic drug use are common in patients with cirrhosis especially in Eastern countries.These patients are at high risk of developing acute-on-chronic liver failure (ACLF) and associated with high short-term mortality. And the natural history of these patients is frequently complicated by bacterial infections, which lead to deterioration of underlying diseases. The present study is aimed to investigate the prevalance and risk factors of bacterial infections in those patients and its impact on in-hospital/short-term mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LC with SALI | – | Other: No interventioncirrhosis patients with severe acute liver injury |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cirrhosis of any etiology who had acute severe liver injury
Key inclusion criteria (2 listed)
- The presence of cirrhosis confirmed by liver biopsy, endoscopy, radiological examination, or clinical evidence of prior hepatic de-compensation;
- Flare up of acute severe liver injury within one month before enrollment. Acute severe liver injury is defined as: increase of serum bilirubin >=85mmol/L and international normalized ratio (INR)>=1.5 with a definite hepatic insult.
Key exclusion criteria (1 listed)
- (1)pregnancy; (2) disseminated maliganancy; (3)previously received a liver transplant; (4) HIV infection;
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 |
|---|---|---|
| No interventionNo intervention | Other | LC with SALI |
Primary outcome
Occurrence of bacterial infection
Time frame: Within 3 months from admission
Site,source, pathogen and severity
2 secondary outcomes
28-day Mortality
Time frame: Within 28 days after enrollment
90-day Mortality
Time frame: Within 90 days after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Jifang Sheng, Doctor study chair
Department of infectious disease, First Affiliated Hospital of Zhejiang University
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 Cirrhosis, Liver and Bacterial Infections, run by The Zhejiang Study Group for Organ Failure in Cirrhosis 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 2 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 6 Jun 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?
Contact Yu Shi, Doctor (86-0571-87236489, zjushiyu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of bacterial infection (time frame: Within 3 months from admission). 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 6 Jun 2018.