Infections in Hospitalized Cirrhotic Patients

NCT03137719 | Completed

• 1 other identifier: 010-294
• Study Type: observational
• Target: 385
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (8)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospitalized cirrhotic patients

You may qualify if:

• 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

You may not qualify if:

• admitted for elective purpose

Sponsors & Collaborators

• Baylor Research Institute: lead

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: May 3, 2017
• Study Start: January 1, 2011
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: August 28, 2020

Record last verified: 2020-02