The Distribution of Plasma Drug Concentrations of Beta-lactam Antibiotics in Intensive Care Unit Patients (TDM-ICU)

March 1, 2016 updated by: Thomas Schon, 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Jönköping, Sweden, 391 85
        • Intensive Care Unit
      • Kalmar, Sweden, 39185
        • Intensive Care Unit
      • Linköping, Sweden, 581 85
        • Intensive Care Unit
      • Växjö, Sweden, 391 85
        • Intensive Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Intensive care unit patients treated with beta-lactam antibiotics

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy, age below 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of patients below 16mg/L for piperacillin-tazobactam, 2 mg/L for meropenem and 4mg/L for cefotaxim
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality in relation to initial levels of beta-lactam antibiotics as defined in primary outcome
Time Frame: 30 days
30 days
The rate of patients below 100% time over MIC in relation to the bacteria causing the infection.
Time Frame: 3 days
3 days
Kidney function measured as eGFR in relation to initial levels of beta-lactam antibiotics as defined in primary outcome
Time Frame: 3 days
3 days
SAPS-score in relation to initial levels of beta-lactam antibiotics as defined in primary outcome
Time Frame: 3 days
3 days
Days in intensive care unit in relation to initial levels of beta-lactam antibiotics as defined in primary outcome
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 24, 2015

First Submitted That Met QC Criteria

May 15, 2015

First Posted (Estimate)

May 18, 2015

Study Record Updates

Last Update Posted (Estimate)

March 3, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • TDM-ICU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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