Prophylactic Antibiotics in Admitted Cirrhotics

  • STATUS
    Recruiting
  • End date
    Jun 1, 2022
  • participants needed
    40
  • sponsor
    Beth Israel Deaconess Medical Center
Updated on 31 July 2021
antibiotics
cirrhosis
elastography
biopsy of liver

Summary

In this pilot study, the investigators aim to assess feasibility of subject identification and data collection, including specimen processing, as well as the rate of enrollment for a future, larger study of the effect of empiric antibiotics for all patients with advanced cirrhosis admitted to the hospital without an existing indication for new antibiotic use. Specifically, the investigators will assess the incidence of infection after the time of enrollment and associated outcomes. Subjects will be randomly assigned to receive antibiotics vs placebo.

Description

Cirrhosis is associated with a state of immune-compromise and progressive decompensation, acute on chronic liver failure (ACLF), and death are often caused by bacterial infections. Different sub-groups of patients with cirrhosis at increased risk, i.e. active upper gastrointestinal hemorrhage, low protein ascites, history of spontaneous bacterial peritonitis (SBP), are known to benefit from prophylactic antibiotics. The investigators hypothesize that hospitalized patients with advanced cirrhosis are also at increased risk and thus may benefit from preventive treatment. Subjects will be randomly assigned to receive an antibiotic vs placebo.

Details
Condition Cirrhosis, Hepatic Fibrosis, hepatic cirrhosis, liver cirrhosis
Treatment Normal saline, ceftriaxone
Clinical Study IdentifierNCT04218695
SponsorBeth Israel Deaconess Medical Center
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

MELD-Na >= 18
Cirrhosis as defined by liver biopsy or a composite assessment of available results from imaging, elastography, prior records, and laboratory studies

Exclusion Criteria

Inability to obtain consent (from subject or next of kin/legal authorized representative (LAR)
Allergy to cephalosporins
Pregnancy (due to limited prospective data regarding safety of ceftriaxone)
Existing indication for new antibiotics, e.g. upper gastrointestinal hemorrhage or apparent infection
Use of major immunosuppressive medications (e.g. prednisone 20 mg/day or greater, immunosuppression for solid organ transplant)
H/o recurrent C difficile infection within the past year (>2) or requiring fecal microbiota transplant (FMT)
Enrollment in the study protocol during a previous admission
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