Infections in Hospitalized Cirrhotic Patients

Completed

• Conditions: Cirrhosis

• Registration Number: NCT03137719
• Lead Sponsor: Baylor Research Institute

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-01
• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-04-28
• Study First Posted: 2017-05-03
• Status Verified: 2020-02
• Primary Completion: 2020-02-26
• Study Completion: 2020-02-26
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patterns and adequacy of albumin use in infected and non-infected patients	From admission to 1 year post-discharge from the hospital	IV albumin administration
Regional variations in outcomes and therapeutic strategies	From admission to 1 year post-discharge from the hospital	Comparison of data between sites conducting this study across the United States and Canada
Frequency, Cause and Outcome of Community-acquired infections	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	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	From admission to 1 year post-discharge from the hospital	Distinctly different from primary infection
Factors predicting ICU care, organ failure, death, and disability	From admission to 1 year post-discharge from the hospital	Admission to the ICU and events/outcomes of that subject's admission
Quality-assurance and adequacy of management of complications of cirrhosis such as hepatic encephalopathy, variceal bleeding, hyponatremia, and hypernatremia	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	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.