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Trial record 15 of 528 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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Infection
Intervention Other: Vancomycin concentrations
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vancomycin Concentrations
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Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.

Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.

Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title Vancomycin Concentrations
Hide Arm/Group Description

Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.

Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.

Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
54.7  (16.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
11
  44.0%
Male
14
  56.0%
1.Primary Outcome
Title Circulating Vancomycin Concentration
Hide Description Blood samples to monitor the vancomycin concentration will be collected at several time points during surgery.
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)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vancomycin Concentrations
Hide Arm/Group Description:

Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.

Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: µg/mL
15.6  (4.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vancomycin Concentrations
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A priori threshold was set to p < 0.05.
Method Mixed Models Analysis
Comments Analyses modeled change in vancomycin concentrations (independent variable defined by time). Analyses were adjusted for covariates.
Method of Estimation Estimation Parameter estimate (beta) from mixed model
Estimated Value -0.068
Confidence Interval (2-Sided) 95%
-0.098 to -0.039
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.015
Estimation Comments Negative beta value indicates that vancomycin concentration decreased following cardiopulmonary bypass (CPB).
Time Frame 12 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vancomycin Concentrations
Hide Arm/Group Description

Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.

Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.

All-Cause Mortality
Vancomycin Concentrations
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vancomycin Concentrations
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vancomycin Concentrations
Affected / at Risk (%)
Total   0/25 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ettore Crimi
Organization: University of Florida
Phone: 617-697-2861
EMail: ettorecrimi@gmail.com
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02051595     History of Changes
Other Study ID Numbers: 201300857
First Submitted: January 29, 2014
First Posted: January 31, 2014
Results First Submitted: June 23, 2015
Results First Posted: July 21, 2015
Last Update Posted: August 13, 2019