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NCT Number: NCT00663403

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

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.

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Key information

Conditions

Critically Ill Critical Illness Disease Attributes Hemodialysis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan University Hospital

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

daptomycin

Drug

Daptomcyin 8 mg/kg infused intravenously every 48 hours

Other names: Cubicin

Primary outcomes

  1. 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.

Secondary outcomes

  1. Daptomycin Dose Actually Administered

    Time frame: Time of daptomycin administration

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 22, 2008
Registry last updated
Dec 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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