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

Early Phase 1

Completed

• Conditions: Infection
• Interventions: Other: Vancomycin concentrations

• Registration Number: NCT02051595
• Lead Sponsor: University of Florida

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-31
• Study Start: 2014-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2015-06-23
• Results First Submitted QC: 2015-06-23
• Results First Posted: 2015-07-21
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-09
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vancomycin concentrations	Vancomycin concentrations	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.

Primary Outcome Measures

Name	Time	Method
Circulating Vancomycin Concentration	Time points: pre CPB (t=1), post CPB at 5 (t=2), 30 (t=3), 60 (t=4), 108 (t=5), 240 (t=6) minutes, prior to ultrafiltration (t=7), end of ultrafiltration (t=8), ultrafiltrate (t=9) ,effluent of cell saver (t=10)	Blood samples to monitor the vancomycin concentration will be collected at several time points during surgery.

Trial Locations

Locations (1)

UF Health; 🇺🇸 Gainesville, Florida, United States