Infections in Hospitalized Cirrhotic Patients

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:

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

Study Overview

• Status: Completed
• Conditions: Cirrhosis

• Study Type: Observational
• Enrollment (Actual): 385

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Hospitalized cirrhotic patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency, Cause and Outcome of Community-acquired infections	Collecting details of infections including type, organism, antibiotic used, length of stay, ICU stay and outcomes	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	From admission to 1 year post-discharge from the hospital
Development of second infections	Distinctly different from primary infection	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	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	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	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.	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	From admission to 1 year post-discharge from the hospital

Collaborators and Investigators

• Sponsor: Baylor Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2011
• Primary Completion (ACTUAL): February 26, 2020
• Study Completion (ACTUAL): February 26, 2020

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (ACTUAL): May 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 010-294

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No