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

December 1, 2015 updated by: University of Michigan
Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU) considering the severity of illness and high risk for infection within this hospital environment. While in the ICU, patients may develop acute renal failure. Approximately 75% of ICU patients who develop acute renal failure will require some form of renal replacement therapy until their kidneys recover. Continuous hemodialysis is becoming one of the most common forms of dialysis in the ICU as it is a gentle type of dialysis provided over longer periods of time. The current data demonstrating the ability of continuous hemodialysis to remove daptomycin from the body is derived from in-vitro trials. The purpose of this trial is to determine the extent of daptomycin removal from critically ill patients receiving continuous hemodialysis. Findings from this trial will be used to develop new dosing recommendations for daptomycin in continuous hemodialysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Daptomycin is a FDA approved antibiotic. This pharmacokinetic trial will monitor daptomycin drug concentrations during continuous hemodialysis. The daptomycin concentration profiles developed from this study will assist in developing a dose recommendation that will result in daptomycin levels that are safe and within therapeutic ranges, as previously identified, in critically ill patients with acute renal failure treated with continuous hemodialysis.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • =/> 18 years of age
  • Prescribed Continuous Venovenous Hemodialysis (CVVHD) as determined by the primary physician
  • Prescribed daptomycin as determined by the primary physician
  • Informed consent granted

Exclusion Criteria:

  • < 18 years of age
  • Allergy to daptomycin
  • Patients being primarily treated with daptomycin for diagnosis of osteomyelitis, meningitis, or pneumonia without adequate concomitant use of other more effective antimicrobial agents as daptomycin is not indicated for primary treatment of these types of infections
  • Inability to complete 48 hours of Continuous Venovenous Hemodialysis (CVVHD)
  • Concurrent use of other extracorporeal therapies such as Extracorporeal Membrane Oxygenation (ECMO) or plasmapheresis and intermittent hemodialysis
  • Inability to obtain informed consent
  • Pregnant and/or breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Quantifies the rate of daptomcyin removal by continuous venovenous hemodialysis.
From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daptomycin Dose Actually Administered
Time Frame: Time of daptomycin administration
Time of daptomycin administration
Observed Daptomycin Peak Serum Concentration
Time Frame: 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.
At the end of the daptomycin intravenous infusion (at approximately 30 minutes)
Daptomycin Volume of Distribution at Steady State
Time Frame: 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.
From time of daptomycin administration to 48 hours post dose
Daptomycin Total Body Clearance
Time Frame: 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.
From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis
Daptomycin Half-life
Time Frame: 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.
From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis
Daptomycin Free Fraction
Time Frame: 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.
From time of daptomycin administration to 48 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Cubist Pharmaceuticals LLC

Investigators

  • Principal Investigator: Bruce A Mueller, PharmD, University of Michigan, College of Pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

April 18, 2008

First Posted (Estimate)

April 22, 2008

Study Record Updates

Last Update Posted (Estimate)

December 30, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 063940
  • HUM00005646 (Other Identifier: U Michigan IRBMED)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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