Trial Outcomes & Findings for Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU Patients (NCT NCT01786161)

NCT ID: NCT01786161

Last Updated: 2017-06-07

Results Overview

The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 44 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2017-06-07

Participant Flow

Participant milestones

Measure	Vancomycin With Continuous Infusion continuous 24 hours intravenous infusion Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion	Vancomycin With Intermittent Dose Interval infusion rate 1000mg/hr Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr
Overall Study STARTED	22	22
Overall Study COMPLETED	22	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU Patients

Baseline characteristics by cohort

Measure	Vancomycin Continous Infusion n=22 Participants Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion infusion rate 1000mg/hr	Intermittent Infusion n=22 Participants infusion rate 1000mg/hr Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr	Total n=44 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 14.1 • n=5 Participants	53.7 years STANDARD_DEVIATION 13.5 • n=7 Participants	56.8 years STANDARD_DEVIATION 14.05 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV

Outcome measures

Measure	Vancomycin With Continuous Infusion n=22 Participants continuous 24 hours intravenous infusion Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion	Vancomycin With Intermittent Dose Interval n=22 Participants infusion rate 1000mg/hr Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr
Number of Participants Who Achieved the Target Vancomycin Concentration	20 Participants	5 Participants

SECONDARY outcome

Timeframe: as long as participants are receiving Vancomycin (mean (SD) 9 (3.8) days for continuous, 8.4 (4.1) days for intermittent)

The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV

Outcome measures

Measure	Vancomycin With Continuous Infusion n=22 Participants continuous 24 hours intravenous infusion Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion	Vancomycin With Intermittent Dose Interval n=22 Participants infusion rate 1000mg/hr Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr
Time Required to Reach the Therapeutic Levels	26.1 hours Standard Deviation 7	54.1 hours Standard Deviation 25.8

SECONDARY outcome

Timeframe: 24 hours

The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV

Outcome measures

Measure	Vancomycin With Continuous Infusion n=22 Participants continuous 24 hours intravenous infusion Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion	Vancomycin With Intermittent Dose Interval n=22 Participants infusion rate 1000mg/hr Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr
Vancomycin Concentration at 24 Hours	19.9 mcg/mL Standard Deviation 3.7	14.2 mcg/mL Standard Deviation 6.6

Adverse Events

Vancomycin Continous Infusion

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Intermittent Infusion

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vancomycin Continous Infusion n=22 participants at risk continuous 24 hours intravenous infusion Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion	Intermittent Infusion n=22 participants at risk infusion rate 1000mg/hr Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr
Renal and urinary disorders Nephrotoxicity	4.5% 1/22 • Adverse event data were collected while subjects are receiving vancomycin therapy. Nephrotoxicity was defined as an increase in serum creatinine (SCr) by 0.5 mg/dL or at least a 50% increase from baseline over 2 consecutive SCr values.	18.2% 4/22 • Adverse event data were collected while subjects are receiving vancomycin therapy. Nephrotoxicity was defined as an increase in serum creatinine (SCr) by 0.5 mg/dL or at least a 50% increase from baseline over 2 consecutive SCr values.

Additional Information

Hsin Lin

Massachusetts General Hospital

Phone: 6177241314

Email: hlin13@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place