Trial Outcomes & Findings for Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis (NCT NCT03685747)
NCT ID: NCT03685747
Last Updated: 2022-03-03
Results Overview
Total systemic plasma concentration following 12-hour dwell
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
4 participants
Primary outcome timeframe
Day: 1
Results posted on
2022-03-03
Participant Flow
Participant milestones
| Measure |
Vancomycin
A single 20 mg/kg intraperitoneal dose in 1-liter of 7.5% icodextrin solution of vancomycin will be administered. Sparse blood sampling will be obtained during an overnight 12-hour dwell and during the exchange period.
Vancomycin: Vancomycin one-time 20 mg/kg intraperitoneal dose.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis
Baseline characteristics by cohort
| Measure |
Vancomycin
n=4 Participants
A single 20 mg/kg intraperitoneal dose in 1-liter of 7.5% icodextrin solution of vancomycin will be administered. Sparse blood sampling will be obtained during an overnight 12-hour dwell and during the exchange period.
Vancomycin: Vancomycin one-time 20 mg/kg intraperitoneal dose.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 19 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day: 1Total systemic plasma concentration following 12-hour dwell
Outcome measures
| Measure |
Vancomycin
n=4 Participants
A single 20 mg/kg intraperitoneal dose in 1-liter of 7.5% icodextrin solution of vancomycin will be administered. Sparse blood sampling will be obtained during an overnight 12-hour dwell and during the exchange period.
Vancomycin: Vancomycin one-time 20 mg/kg intraperitoneal dose.
|
|---|---|
|
Maximum Total Plasma Concentration (Cmax)
|
28.7 mg/L
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: Day: 1Time (hours) to achieve the maximum plasma concentration
Outcome measures
| Measure |
Vancomycin
n=4 Participants
A single 20 mg/kg intraperitoneal dose in 1-liter of 7.5% icodextrin solution of vancomycin will be administered. Sparse blood sampling will be obtained during an overnight 12-hour dwell and during the exchange period.
Vancomycin: Vancomycin one-time 20 mg/kg intraperitoneal dose.
|
|---|---|
|
Time to Maximum Plasma Concentration (Tmax)
|
14.4 hours
Interval 13.8 to 15.0
|
PRIMARY outcome
Timeframe: Days: 1-7AUC based on vancomycin plasma concentrations
Outcome measures
| Measure |
Vancomycin
n=4 Participants
A single 20 mg/kg intraperitoneal dose in 1-liter of 7.5% icodextrin solution of vancomycin will be administered. Sparse blood sampling will be obtained during an overnight 12-hour dwell and during the exchange period.
Vancomycin: Vancomycin one-time 20 mg/kg intraperitoneal dose.
|
|---|---|
|
Area Under the Concentration-time Curve (AUC0-inf)
|
2589.9 hr x mg/L
Standard Deviation 365.6
|
PRIMARY outcome
Timeframe: Days: 1-7Total vancomycin plasma vancomycin clearance
Outcome measures
| Measure |
Vancomycin
n=4 Participants
A single 20 mg/kg intraperitoneal dose in 1-liter of 7.5% icodextrin solution of vancomycin will be administered. Sparse blood sampling will be obtained during an overnight 12-hour dwell and during the exchange period.
Vancomycin: Vancomycin one-time 20 mg/kg intraperitoneal dose.
|
|---|---|
|
Total Body Clearance (CLtotal)
|
7.2 mL/min
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Days: 1-7Vancomycin clearance from peritoneal dialysis
Outcome measures
| Measure |
Vancomycin
n=4 Participants
A single 20 mg/kg intraperitoneal dose in 1-liter of 7.5% icodextrin solution of vancomycin will be administered. Sparse blood sampling will be obtained during an overnight 12-hour dwell and during the exchange period.
Vancomycin: Vancomycin one-time 20 mg/kg intraperitoneal dose.
|
|---|---|
|
Dialytic Clearance
|
11.1 mL/min
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Days: 1-7Any adverse events throughout entirety of study as assessed by physician-investigator
Outcome measures
| Measure |
Vancomycin
n=4 Participants
A single 20 mg/kg intraperitoneal dose in 1-liter of 7.5% icodextrin solution of vancomycin will be administered. Sparse blood sampling will be obtained during an overnight 12-hour dwell and during the exchange period.
Vancomycin: Vancomycin one-time 20 mg/kg intraperitoneal dose.
|
|---|---|
|
Adverse Events
|
0 Participants
|
Adverse Events
Vancomycin
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place