Trial Outcomes & Findings for Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis (NCT NCT00877370)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

24 hours after receiving first 1 gram dose

Results posted on

2012-09-28

Participant Flow

Subjects were consented and enrolled between April 2009 and March 2011. All subjects were patients receiving care in an intensive care unit at University of Michigan Health System.

All patients that qualified for the study were approached. All subjects that gave their consent were enrolled.

Participant milestones

Participant milestones
Measure	Ertapenem Subjects will receive ertapenem while receiving CVVHD ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ertapenem n=8 Participants Subjects will receive ertapenem while receiving CVVHD ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age Continuous	62 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours after receiving first 1 gram dose

Population: All participants were included in the analysis.

Outcome measures

Outcome measures
Measure	Ertapenem n=8 Participants Subjects will receive ertapenem while receiving CVVHD ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained.
Ertapenem Transmembrane Clearance by Continuous Hemodialysis.	10.4 mL/min Standard Deviation 4.2

Adverse Events

Ertapenem

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

Bruce A. Mueller

University of Michigan

Phone: (734) 615-4578

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place