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OpenTrials
Completed

NCT Number: NCT03137719

Infections in Hospitalized Cirrhotic Patients

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

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Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Frequency, Cause and Outcome of Community-acquired infections

    Time frame: 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

  2. Frequency, Cause, and Outcome of Nosocomial infections

    Time frame: 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

  3. Development of second infections

    Time frame: From admission to 1 year post-discharge from the hospital

    Distinctly different from primary infection

  4. Factors predicting ICU care, organ failure, death, and disability

    Time frame: From admission to 1 year post-discharge from the hospital

    Admission to the ICU and events/outcomes of that subject's admission

  5. Patterns and adequacy of albumin use in infected and non-infected patients

    Time frame: From admission to 1 year post-discharge from the hospital

    IV albumin administration

  6. Quality-assurance and adequacy of management of complications of cirrhosis such as hepatic encephalopathy, variceal bleeding, hyponatremia, and hypernatremia

    Time frame: From admission to 1 year post-discharge from the hospital

    Blood test and other obvious clinical evidence of decompensation

  7. Peri and post-liver transplant outcomes based on physiological parameters

    Time frame: 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.

  8. Regional variations in outcomes and therapeutic strategies

    Time frame: From admission to 1 year post-discharge from the hospital

    Comparison of data between sites conducting this study across the United States and Canada

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
May 3, 2017
Registry last updated
Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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