CirrhosisNCT01872767
Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure
An observational study of Cirrhosis and Acute Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
After successful screening diagnosis of cirrhosis and/or acute or chronic liver failure will be made. These patients will undergo detail clinical, biochemical and microbiological examination at baseline. Clinical examination and Biochemical evaluation will be done daily and signs of infection will be noted. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cirrhosis, Acute Liver Failure, Chronic Liver Failure
- How many people
- 522 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2013to Nov 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary Care Center.
Who may be able to join
- A clinical, radiological or histological diagnosis of cirrhosis and/or ACLF (Acute on Chronic Liver Failure).
- Age > 18years
Who cannot join
- Previous liver transplantation.
- Patients who died within 8 hours of ICU (Intensive Care Unit) admission.
- Acute liver failure
- Lack of consent
- Patient on steroids/ or any other immunosuppressive medication
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences.
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure Admitted in Liver Specialty ICU (Intensive Care Unit)- An Observational Study
After successful screening diagnosis of cirrhosis and/or acute or chronic liver failure will be made. These patients will undergo detail clinical, biochemical and microbiological examination at baseline. Clinical examination and Biochemical evaluation will be done daily and signs of infection will be noted. Patients will undergo microbiological screening for infection every 48 hours. Patients suspected or diagnosed to be suffering from infections will be treated as per ILBS (Institute of Liver and Biliary Sciences) antibiotic policy. Site and etiology (bacterial and/or fungal) of infections will be noted in all patients at admission in liver specialty ICU (Intensive Care Unit) and during the ICU (Intensive Care Unit) stay. All the patients will be followed until discharge or death in ICU (Intensive Care Unit).
- Conditions
- Cirrhosis, Acute Liver Failure, Chronic Liver Failure
- Keywords
- Acute on Chronic Liver Failure (ACLF),Cirrhosis,, Institute of Liver & Biliary Sciences (ILBS)
- Medical subject headings
- Fibrosis, Liver Failure, Acute, End Stage Liver Disease, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cirrhotics/ Acute on chronic liver failure admitted to ICU | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality within 1 month during ICU (Intensive Care Unit) stay.
Measured: 30 days
Secondary outcomes (3)
Number of days stayed in ICU (Intensive Care Unit).
Measured: 30 days
Risk factors determination in development of multidrug resistance bacteria.Risk factors are defined as Nosocomial infection,Recent Hospitalization, recent antibiotic usage, SBP (spontaneous bacterial peritonitis)prophylaxis, diabetes etc
Measured: 30 days
Proportion of patients with organ failure.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amrish Sahney, MD, Principal investigator, Institute of Liver & Biliary Sciences.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872767
- Sponsor's protocol ID
- ILBS-ACLF-0003
- Status last verified
- Nov 2014
- First submitted
- 27 Apr 2013
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure Admitted in Liver Specialty ICU (Intensive Care Unit)- An Observational Study
- ClinicalTrials.gov ID
- NCT01872767
- Acronym / sponsor ID
- ILBS-ACLF-0003
- Conditions
- Cirrhosis, Acute Liver Failure, Chronic Liver Failure
- Keywords
- Acute on Chronic Liver Failure (ACLF),Cirrhosis,, Institute of Liver & Biliary Sciences (ILBS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Jun 2013 (estimated)
- 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.
After successful screening diagnosis of cirrhosis and/or acute or chronic liver failure will be made. These patients will undergo detail clinical, biochemical and microbiological examination at baseline. Clinical examination and Biochemical evaluation will be done daily and signs of infection will be noted. Patients will undergo microbiological screening for infection every 48 hours. Patients suspected or diagnosed to be suffering from infections will be treated as per ILBS (Institute of Liver and Biliary Sciences) antibiotic policy. Site and etiology (bacterial and/or fungal) of infections will be noted in all patients at admission in liver specialty ICU (Intensive Care Unit) and during the ICU (Intensive Care Unit) stay. All the patients will be followed until discharge or death in ICU (Intensive Care Unit).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cirrhotics/ Acute on chronic liver failure admitted to ICU | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary Care Center.
Key inclusion criteria (2 listed)
- A clinical, radiological or histological diagnosis of cirrhosis and/or ACLF (Acute on Chronic Liver Failure).
- Age > 18years
Key exclusion criteria (5 listed)
- Previous liver transplantation.
- Patients who died within 8 hours of ICU (Intensive Care Unit) admission.
- Acute liver failure
- Lack of consent
- Patient on steroids/ or any other immunosuppressive medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality within 1 month during ICU (Intensive Care Unit) stay.
Time frame: 30 days
3 secondary outcomes
Number of days stayed in ICU (Intensive Care Unit).
Time frame: 30 days
Risk factors determination in development of multidrug resistance bacteria.Risk factors are defined as Nosocomial infection,Recent Hospitalization, recent antibiotic usage, SBP (spontaneous bacterial peritonitis)prophylaxis, diabetes etc
Time frame: 30 days
Proportion of patients with organ failure.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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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.
Amrish Sahney, MD principal investigator
Institute of Liver & Biliary Sciences.
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 and Acute Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 5 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: finished, as of the sponsor's last update on 27 May 2015. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality within 1 month during ICU (Intensive Care Unit) stay. (time frame: 30 days). 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 27 May 2015.