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Completed

NCT Number: NCT03004066

Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients

10 patients with chronic heart failure receiving daptomycin therapy after implantation of a left ventricular heart assist system. Measurement of daptomycin levels in drainage fluids (mediastinal and pleural drainage systems) and in blood samples.

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Key information

Conditions

Heart Assist Device

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Tuebingen

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • written consent
  • heart assist device implantation
  • wound drainage
  • daptomycin therapy

Exclusion criteria

  • pregnancy
  • no written consent possible
  • absence of wound drainage
  • allergy to study medication
  • acute rhabdomyolysis

Treatment and study plan

daptomycin

Drug

standard care

Primary outcomes

  1. levels of Daptomycin in drainage fluid

    Time frame: 4 days

    Pharmacokinetics of Daptomycin in intensive care patients with wound drainage after surgery (LVAD implantation)

  2. levels of Daptomycin in blood samples

    Time frame: 4 days

    Pharmacokinetics of Daptomycin in intensive care patients after surgery (LVAD implantation)

Secondary outcomes

  1. infections

    Time frame: 14 days

    incidence of gram-positive infections

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 28, 2016
Registry last updated
Apr 19, 2019

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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