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

Condition(s) targeted: Sepsis

Intervention: No intervention. (Other)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Linkoeping University

Official(s) and/or principal investigator(s):
Thomas Schön, MD PhD, Principal Investigator, Affiliation: Linkoeping University

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.

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: The rate of patients below 16mg/L for piperacillin-tazobactam, 2 mg/L for meropenem and 4mg/L for cefotaxim

Secondary outcome:

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

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

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

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- Pregnancy, age below 18 years

Intensive care unit, Jönköping 391 85, Sweden

Intensive Care Unit, Kalmar 39185, Sweden

Intensive Care Unit, Linköping 581 85, Sweden

Intensive care unit, Växjö 391 85, Sweden

Related publications:

Udy AA, Roberts JA, Lipman J. Clinical implications of antibiotic pharmacokinetic principles in the critically ill. Intensive Care Med. 2013 Dec;39(12):2070-82. doi: 10.1007/s00134-013-3088-4. Epub 2013 Sep 18. Review.

Starting date: October 2014
Last updated: August 21, 2015