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Completed

NCT Number: NCT02446392

The Distribution of Plasma Drug Concentrations of Beta-lactam Antibiotics in Intensive Care Unit Patients

In this project, intensive care unit (ICU) patients treated with beta-lactam antibiotics are included with the aim to investigate the potential underdosing in this patient group. Four regional ICU-clinics are recruiting consecutive patients (n=120) and samples are taken before the next dose is administered for three consecutive days.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensive care unit, Jönköping, Jönköping County, Sweden

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Current treatment with beta-lactam antibiotics and admission to the ICU

Exclusion criteria

  • Pregnancy, age below 18 years

Treatment and study plan

No intervention.

Other

Primary outcomes

  1. The rate of patients below 16mg/L for piperacillin-tazobactam, 2 mg/L for meropenem and 4mg/L for cefotaxim

    Time frame: 3 days

Secondary outcomes

  1. Mortality in relation to initial levels of beta-lactam antibiotics as defined in primary outcome

    Time frame: 30 days

  2. The rate of patients below 100% time over MIC in relation to the bacteria causing the infection.

    Time frame: 3 days

  3. Kidney function measured as eGFR in relation to initial levels of beta-lactam antibiotics as defined in primary outcome

    Time frame: 3 days

  4. SAPS-score in relation to initial levels of beta-lactam antibiotics as defined in primary outcome

    Time frame: 3 days

  5. Days in intensive care unit in relation to initial levels of beta-lactam antibiotics as defined in primary outcome

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Acronym: TDM-ICU

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
May 18, 2015
Registry last updated
Mar 3, 2016

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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