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

University of Florida logo

University of Florida

Status and phase

Completed
Early Phase 1

Conditions

Infection

Treatments

Other: Vancomycin concentrations

Study type

Interventional

Funder types

Other

Identifiers

NCT02051595
201300857

Details and patient eligibility

About

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.

Full description

Subjects having cardiac surgery in which they will be on a heart-lung machine and will receive the antibiotic vancomycin, will be able to participate.

Up to ten blood samples testing for vancomycin concentrations will be collected in subjects administered vancomycin as prophylaxis before cardiac surgery with cardiopulmonary bypass and modified ultrafiltration. Participation will be complete once the cardiac surgery has been finished.

Enrollment

25 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Vancomycin concentrations
Other group
Description:
Up to ten blood samples testing for vancomycin concentrations will be collected in subjects administered vancomycin as prophylaxis before cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.
Treatment:
Other: Vancomycin concentrations

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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