CirrhosisNCT03137719
Infections in Hospitalized Cirrhotic Patients
An observational study of Cirrhosis, run by Baylor Research Institute.
Trial summary
Hospitalized cirrhotic patients are at high risk of complications and adverse outcomes. This study aims to determine the current practice and outcomes in these following areas: 1. Community-acquired infections 2. Nosocomial infections 3. Development of second infections 4. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- How many people
- 385 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 26 Feb 2020
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Hospitalized cirrhotic patients
Who may be able to join
- Male and Female over 18 years of age
- Cirrhosis as diagnosed by either liver histology or a combination of clinical biochemical (low platelets, elevated bilirubin, and/or INR, low albumin) radiologic (nodular liver on ultrasound) and endoscopic (esophageal varices) criteria
- Subject must be able to understand and provide informed consent
- Evaluated in the ER or admitted to the hospital for non-elective reasons
Who cannot join
- admitted for elective purpose
About this study
Official title: Infections and Other Complications of Cirrhosis: A Prospective Multi-Center Study
Hospitalized cirrhotic patients are at high risk of complications and adverse outcomes. This study aims to determine the current practice and outcomes in these following areas:
- Community-acquired infections
- Nosocomial infections
- Development of second infections
- Factors predicting ICU care, organ failure, death, and disability
- Patterns and adequacy of albumin use in infected and non-infected patients
- Per and post-liver transplant outcomes
- Quality-assurance and adequacy of management of complications of cirrhosis such as hepatic encephalopathy, variceal bleeding, hyponatremia, and hypernatremia
- Regional variations in outcomes and therapeutic strategies
- Conditions
- Cirrhosis
- Medical subject headings
- Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency, Cause and Outcome of Community-acquired infections
Collecting details of infections including type, organism, antibiotic used, length of stay, ICU stay and outcomes
Measured: From admission to 1 year post-discharge from the hospital
Frequency, Cause, and Outcome of Nosocomial infections
Collecting details of infections including type, organism, antibiotic used, length of stay, ICU stay and outcomes
Measured: From admission to 1 year post-discharge from the hospital
Development of second infections
Distinctly different from primary infection
Measured: From admission to 1 year post-discharge from the hospital
Factors predicting ICU care, organ failure, death, and disability
Admission to the ICU and events/outcomes of that subject's admission
Measured: From admission to 1 year post-discharge from the hospital
Patterns and adequacy of albumin use in infected and non-infected patients
IV albumin administration
Measured: From admission to 1 year post-discharge from the hospital
Quality-assurance and adequacy of management of complications of cirrhosis such as hepatic encephalopathy, variceal bleeding, hyponatremia, and hypernatremia
Blood test and other obvious clinical evidence of decompensation
Measured: From admission to 1 year post-discharge from the hospital
Peri and post-liver transplant outcomes based on physiological parameters
Collection of liver transplant donor and recipient information such as blood group, CMV status, post-transplant infections, immunosuppression regimen, and prophylaxis given.
Measured: From admission to 1 year post-discharge from the hospital
Regional variations in outcomes and therapeutic strategies
Comparison of data between sites conducting this study across the United States and Canada
Measured: From admission to 1 year post-discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start1 Jan 2011
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
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 Baylor Research InstituteThe 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
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137719
- Sponsor's protocol ID
- 010-294
- Status last verified
- Feb 2020
- First submitted
- 27 Mar 2017
- Last updated
- 28 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infections and Other Complications of Cirrhosis: A Prospective Multi-Center Study
- ClinicalTrials.gov ID
- NCT03137719
- Acronym / sponsor ID
- 010-294
- Conditions
- Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 3 May 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.
Hospitalized cirrhotic patients are at high risk of complications and adverse outcomes. This study aims to determine the current practice and outcomes in these following areas:
- Community-acquired infections
- Nosocomial infections
- Development of second infections
- Factors predicting ICU care, organ failure, death, and disability
- Patterns and adequacy of albumin use in infected and non-infected patients
- Per and post-liver transplant outcomes
- Quality-assurance and adequacy of management of complications of cirrhosis such as hepatic encephalopathy, variceal bleeding, hyponatremia, and hypernatremia
- Regional variations in outcomes and therapeutic strategies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hospitalized cirrhotic patients
Key inclusion criteria (4 listed)
- Male and Female over 18 years of age
- Cirrhosis as diagnosed by either liver histology or a combination of clinical biochemical (low platelets, elevated bilirubin, and/or INR, low albumin) radiologic (nodular liver on ultrasound) and endoscopic (esophageal varices) criteria
- Subject must be able to understand and provide informed consent
- Evaluated in the ER or admitted to the hospital for non-elective reasons
Key exclusion criteria (1 listed)
- admitted for elective purpose
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
Frequency, Cause and Outcome of Community-acquired infections
Time frame: From admission to 1 year post-discharge from the hospital
Collecting details of infections including type, organism, antibiotic used, length of stay, ICU stay and outcomes
Frequency, Cause, and Outcome of Nosocomial infections
Time frame: From admission to 1 year post-discharge from the hospital
Collecting details of infections including type, organism, antibiotic used, length of stay, ICU stay and outcomes
Development of second infections
Time frame: From admission to 1 year post-discharge from the hospital
Distinctly different from primary infection
Factors predicting ICU care, organ failure, death, and disability
Time frame: From admission to 1 year post-discharge from the hospital
Admission to the ICU and events/outcomes of that subject's admission
Patterns and adequacy of albumin use in infected and non-infected patients
Time frame: From admission to 1 year post-discharge from the hospital
IV albumin administration
Quality-assurance and adequacy of management of complications of cirrhosis such as hepatic encephalopathy, variceal bleeding, hyponatremia, and hypernatremia
Time frame: From admission to 1 year post-discharge from the hospital
Blood test and other obvious clinical evidence of decompensation
Peri and post-liver transplant outcomes based on physiological parameters
Time frame: From admission to 1 year post-discharge from the hospital
Collection of liver transplant donor and recipient information such as blood group, CMV status, post-transplant infections, immunosuppression regimen, and prophylaxis given.
Regional variations in outcomes and therapeutic strategies
Time frame: From admission to 1 year post-discharge from the hospital
Comparison of data between sites conducting this study across the United States and Canada
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 28 Aug 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, run by Baylor Research Institute.
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 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: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Frequency, Cause and Outcome of Community-acquired infections (time frame: From admission to 1 year post-discharge from the hospital). The study lists 8 primary outcomes in all. 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 28 Aug 2020.