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

Infection research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Infection

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Vancomycin concentrationsUp 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Vancomycin concentrationsUp 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.

Study Status

Completed

Start Date: April 2014

Completed Date: April 2015

Phase: Early Phase 1

Type: Interventional

Design:

Primary Outcome: Circulating Vancomycin Concentration

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Ettore Crimi, MD

Lead Sponsor: University of Florida

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02051595

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