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

Sepsis Clinical Trial

— TDM-ICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02446392
• Other study ID #: TDM-ICU
• Status: Completed
• Phase: N/A
• First received: April 24, 2015
• Last updated: March 1, 2016
• Start date: October 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy, age below 18 years

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis

Intervention

Other:
• No intervention.

Locations

Country	Name	City	State
Sweden	Intensive care unit	Jönköping
Sweden	Intensive Care Unit	Kalmar
Sweden	Intensive Care Unit	Linköping
Sweden	Intensive care unit	Växjö

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of patients below 16mg/L for piperacillin-tazobactam, 2 mg/L for meropenem and 4mg/L for cefotaxim		3 days	No
Secondary	Mortality in relation to initial levels of beta-lactam antibiotics as defined in primary outcome		30 days	No
Secondary	The rate of patients below 100% time over MIC in relation to the bacteria causing the infection.		3 days	No
Secondary	Kidney function measured as eGFR in relation to initial levels of beta-lactam antibiotics as defined in primary outcome		3 days	No
Secondary	SAPS-score in relation to initial levels of beta-lactam antibiotics as defined in primary outcome		3 days	No
Secondary	Days in intensive care unit in relation to initial levels of beta-lactam antibiotics as defined in primary outcome		30 days	No