Early Phase 1 N=25 Basic Science

The Effects of Modified Ultrafiltration on Vancomycin Levels During Cardiopulmonary Bypass in Cardiac Surgery

Infection

Bottom Line

View on ClinicalTrials.gov: NCT02051595 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2015

Primary outcome: Primary: Circulating Vancomycin Concentration — 15.6 µg/mL — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Vancomycin concentrations (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Apr 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Circulating Vancomycin Concentration	15.6	<0.0001 sig

Summary

Antibiotics are routinely used to prevent surgical wound infection. Vancomycin is a widely used antibiotic for surgery in patients with an allergy to penicillin. During cardiac surgery, cardiopulmonary bypass (CPB) and modified ultrafiltration (MUF) are routinely used and can lower the level of the antibiotic. The purpose of this study is to quantify the change in plasma vancomycin concentration associated with cardiopulmonary bypass and modified ultrafiltration.

Eligibility Criteria

Inclusion Criteria

Scheduled to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration
age greater than 18 years old
penicillin allergy or in-hospital stay greater than 24 hours
normal renal function
normal liver function
absence of clinical and laboratory signs of infection

Exclusion Criteria

vancomycin allergy
pregnancy
impaired renal function
impaired liver function
morbid obesity
active infections
Jehovah's Witness

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Data sourced from ClinicalTrials.gov (NCT02051595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.