Trial Outcomes & Findings for Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD) (NCT NCT00663403)

Results Overview

Quantifies the rate of daptomcyin removal by continuous venovenous hemodialysis.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis

Results posted on

2015-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	Daptomycin in Continuous Renal Replacement Therapy (CRRT) This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daptomycin in Continuous Renal Replacement Therapy (CRRT) n=8 Participants This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	51 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis

Quantifies the rate of daptomcyin removal by continuous venovenous hemodialysis.

Outcome measures

Outcome measures
Measure	Daptomycin in Continuous Renal Replacement Therapy (CRRT) n=8 Participants This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis	6.3 mL/min Standard Deviation 2.9

SECONDARY outcome

Timeframe: Time of daptomycin administration

Outcome measures

Outcome measures
Measure	Daptomycin in Continuous Renal Replacement Therapy (CRRT) n=8 Participants This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
Daptomycin Dose Actually Administered	7.7 mg/kg Standard Deviation 0.6

SECONDARY outcome

Timeframe: At the end of the daptomycin intravenous infusion (at approximately 30 minutes)

The maximum concentration of daptomycin in the body after receiving a dose of the drug. This was determined at the end of the daptomycin intravenous infusion at approximately 30 min.

Outcome measures

Outcome measures
Measure	Daptomycin in Continuous Renal Replacement Therapy (CRRT) n=8 Participants This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
Observed Daptomycin Peak Serum Concentration	81.2 ug/mL Standard Deviation 19.0

SECONDARY outcome

Timeframe: From time of daptomycin administration to 48 hours post dose

Volume of distribution quantifies the distribution of daptomycin between the blood and the rest of the body. The greater the volume of distribtion, the greater the extent of daptomycin distribution throughout the body.

Outcome measures

Outcome measures
Measure	Daptomycin in Continuous Renal Replacement Therapy (CRRT) n=8 Participants This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
Daptomycin Volume of Distribution at Steady State	0.23 L/kg Standard Deviation 0.14

SECONDARY outcome

Timeframe: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis

Total body clearance represents the rate at which daptomycin is removed from the body. In patients treated with continuous venovenous hemodialysis, the major pathways of daptomycin removal likely are: removal by continuuous venovenous hemodialysis (transmembrane clearance) and breakdown by the liver.

Outcome measures

Outcome measures
Measure	Daptomycin in Continuous Renal Replacement Therapy (CRRT) n=8 Participants This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
Daptomycin Total Body Clearance	0.13 mL/min/kg Standard Deviation 0.04

SECONDARY outcome

Timeframe: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis

Half-life describes the time it takes for the concentration of the daptomycin in the body to decrease by one half.

Outcome measures

Outcome measures
Measure	Daptomycin in Continuous Renal Replacement Therapy (CRRT) n=8 Participants This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
Daptomycin Half-life	20.8 hours Standard Deviation 16.5

SECONDARY outcome

Timeframe: From time of daptomycin administration to 48 hours post dose

In the body, daptomcyin may be bound to proteins in the blood or it may not be bound to any proteins (also as the "free" component.) Free fraction describes the percent of daptomycin that is unbound or free. The unbound portion of daptomycin is able to kill bacteria.

Outcome measures

Outcome measures
Measure	Daptomycin in Continuous Renal Replacement Therapy (CRRT) n=8 Participants This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
Daptomycin Free Fraction	17.5 percent protein binding Standard Deviation 5.0

Adverse Events

Daptomycin in Continuous Renal Replacement Therapy (CRRT)

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 College of Pharmacy

Phone: 7347636629

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place