The Effects of Modified Ultrafiltration on Vancomycin Levels During Cardiopulmonary Bypass in Cardiac Surgery
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Apr 2014
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2014
CompletedFirst Posted
Study publicly available on registry
January 31, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
July 21, 2015
CompletedAugust 13, 2019
August 1, 2019
1 year
January 29, 2014
June 23, 2015
August 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
Vancomycin concentrations
OTHERUp 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- vancomycin allergy
- pregnancy
- impaired renal function
- impaired liver function
- morbid obesity
- active infections
- Jehovah's Witness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UF Health
Gainesville, Florida, 32610, United States
MeSH Terms
Conditions
Results Point of Contact
- Title
- Dr. Ettore Crimi
- Organization
- University of Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Ettore Crimi, MD
University of Florida
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2014
First Posted
January 31, 2014
Study Start
April 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
August 13, 2019
Results First Posted
July 21, 2015
Record last verified: 2019-08