Infections in Hospitalized Cirrhotic Patients

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137719
• Other study ID #: 010-294
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: February 26, 2020

Study information

• Verified date: February 2020
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Development of second infections	Distinctly different from primary infection	From admission to 1 year post-discharge from the hospital
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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