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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051595
• Other study ID #: 201300857
• Status: Completed
• Phase: Early Phase 1
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: August 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	UF Health	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating Vancomycin Concentration	Blood samples to monitor the vancomycin concentration will be collected at several time points during surgery.	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)