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

This study has been completed.

Study NCT00663403 Information provided by University of Michigan

First Received on April 18, 2008. Last Updated on August 27, 2010 History of Changes

Results First Received: April 29, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Single Group Assignment; Masking: Open Label
Conditions:	Critically Ill Hemodialysis
Intervention:	Drug: Daptomycin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Daptomycin in Continuous Renal Replacement Therapy (CRRT)
STARTED	8
COMPLETED	8
NOT COMPLETED	0
everyone completed trial	0

Baseline Characteristics

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Reporting Groups

	Description
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.

Baseline Measures

	Daptomycin in Continuous Renal Replacement Therapy (CRRT)
Number of Participants [units: participants]	8
Age [units: participants]
<=18 years	0
Between 18 and 65 years	6
>=65 years	2
Age [units: years] Mean ± Standard Deviation	51 ± 14
Gender [units: participants]
Female	3
Male	5
Region of Enrollment [units: participants]
United States	8

Outcome Measures

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1. Primary:

Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis [ Time Frame: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis ]

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2. Secondary:

Daptomycin Dose Actually Administered [ Time Frame: Time of daptomycin administration ]

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3. Secondary:

Observed Daptomycin Peak Serum Concentration [ Time Frame: At the end of the daptomycin intravenous infusion (at approximately 30 minutes) ]

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4. Secondary:

Daptomycin Volume of Distribution at Steady State [ Time Frame: From time of daptomycin administration to 48 hours post dose ]

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5. Secondary:

Daptomycin Total Body Clearance [ Time Frame: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis ]

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6. Secondary:

Daptomycin Half-life [ Time Frame: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis ]

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7. Secondary:

Daptomycin Free Fraction [ Time Frame: From time of daptomycin administration to 48 hours post dose ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Transmembrane and total body clearance results limited to continuous venovenous hemodialysis run at ~2 L/h dialysate flow. Clinical outcomes (such as infection cure rate, length of hospital stay, mortality rate) of subjects was not assessed.

Results Point of Contact:

Name/Title: Bruce A. Mueller
Organization: University of Michigan College of Pharmacy
phone: 7347636629
e-mail: muellerb@umich.edu

No publications provided by University of Michigan

Publications automatically indexed to this study:

Vilay AM, Grio M, Depestel DD, Sowinski KM, Gao L, Heung M, Salama NN, Mueller BA. Daptomycin pharmacokinetics in critically ill patients receiving continuous venovenous hemodialysis. Crit Care Med. 2011 Jan;39(1):19-25.

Responsible Party:	Bruce A. Mueller, University of Michigan, College of Pharmacy
ClinicalTrials.gov Identifier:	NCT00663403 History of Changes
Other Study ID Numbers:	063940, HUM00005646
Study First Received:	April 18, 2008
Results First Received:	April 29, 2010
Last Updated:	August 27, 2010
Health Authority:	United States: Food and Drug Administration