Trial Outcomes & Findings for The Effects of Modified Ultrafiltration on Vancomycin Levels During Cardiopulmonary Bypass in Cardiac Surgery (NCT NCT02051595)

Results Overview

Blood samples to monitor the vancomycin concentration will be collected at several time points during surgery.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

25 participants

Primary outcome timeframe

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)

Results posted on

2019-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	Vancomycin Concentrations 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 Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vancomycin Concentrations n=25 Participants 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.
Age, Continuous	54.7 years STANDARD_DEVIATION 16.1 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vancomycin Concentrations n=25 Participants 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.
Circulating Vancomycin Concentration	15.6 µg/mL Standard Deviation 4.4

Adverse Events

Vancomycin Concentrations

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ettore Crimi

University of Florida

Phone: 617-697-2861

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place