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Trial record 15 of 530 for:    VANCOMYCIN

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

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ClinicalTrials.gov Identifier: NCT02051595
Recruitment Status : Completed
First Posted : January 31, 2014
Results First Posted : July 21, 2015
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Infection Other: Vancomycin concentrations Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Modified Ultrafiltration on Vancomycin Levels During Cardiopulmonary Bypass in Cardiac Surgery
Study Start Date : April 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
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.
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.
Other Names:
  • pharmacodynamics
  • vancomycin monitoring
  • serum concentrations of vancomycin




Primary Outcome Measures :
  1. Circulating Vancomycin Concentration [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051595


Locations
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United States, Florida
UF Health
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Ettore Crimi, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02051595     History of Changes
Other Study ID Numbers: 201300857
First Posted: January 31, 2014    Key Record Dates
Results First Posted: July 21, 2015
Last Update Posted: August 13, 2019
Last Verified: August 2019
Keywords provided by University of Florida:
heart lung machine
blood pump
cardiac surgery
cardiopulmonary bypass
circulation
Additional relevant MeSH terms:
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Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents