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Infections in Hospitalized Cirrhotic Patients

Infections and Other Complications of Cirrhosis: A Prospective Multi-Center Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03137719
Enrollment
385
Registered
2017-05-03
Start date
2011-01-01
Completion date
2020-02-26
Last updated
2020-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

Brief 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. Factors predicting ICU care, organ failure, death, and disability 5. Patterns and adequacy of albumin use in infected and non-infected patients 6. Per and post-liver transplant outcomes 7. Quality-assurance and adequacy of management of complications of cirrhosis such as hepatic encephalopathy, variceal bleeding, hyponatremia, and hypernatremia 8. Regional variations in outcomes and therapeutic strategies

Interventions

None listed

Sponsors

Baylor Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* 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

Exclusion criteria

* admitted for elective purpose

Design outcomes

Primary

MeasureTime frameDescription
Frequency, Cause, and Outcome of Nosocomial infectionsFrom admission to 1 year post-discharge from the hospitalCollecting details of infections including type, organism, antibiotic used, length of stay, ICU stay and outcomes
Frequency, Cause and Outcome of Community-acquired infectionsFrom admission to 1 year post-discharge from the hospitalCollecting details of infections including type, organism, antibiotic used, length of stay, ICU stay and outcomes
Factors predicting ICU care, organ failure, death, and disabilityFrom admission to 1 year post-discharge from the hospitalAdmission to the ICU and events/outcomes of that subject's admission
Development of second infectionsFrom admission to 1 year post-discharge from the hospitalDistinctly different from primary infection
Patterns and adequacy of albumin use in infected and non-infected patientsFrom admission to 1 year post-discharge from the hospitalIV albumin administration
Quality-assurance and adequacy of management of complications of cirrhosis such as hepatic encephalopathy, variceal bleeding, hyponatremia, and hypernatremiaFrom admission to 1 year post-discharge from the hospitalBlood test and other obvious clinical evidence of decompensation
Peri and post-liver transplant outcomes based on physiological parametersFrom admission to 1 year post-discharge from the hospitalCollection 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 strategiesFrom admission to 1 year post-discharge from the hospitalComparison of data between sites conducting this study across the United States and Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026