Optimization of PK/PD Target Attainment for Meropenem in Critically Ill Patients With Sepsis

January 21, 2021 updated by: Matthias Gijsen, Universitaire Ziekenhuizen KU Leuven
WP1.1. PK/PD target attainment: Plasma exposure, Excretion via urine & ELF exposure; WP1.2. Predictive dosing algorithm; WP1.3. ECMO subset

Study Overview

Status

Completed

Conditions

Detailed Description

First, the investigators will document exposure to meropenem in plasma and epithelial lining fluid. Moreover excretion in urine will be documented.

Second, the investigators will try to identify risk factors for not attaining PK/PD target. Based on significant predictors for target non attainment a predictive dosing algorithm will be constructed.

Finally in a small subset of ECMO patients PK exposure will be explored.

Study Type

Observational

Enrollment (Actual)

116

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

Probability Sample

Study Population

Critically ill patients with sepsis and receiving meropenem

Description

Inclusion Criteria:

  • Severe sepsis or septic shock
  • Admitted to an ICU ward
  • Treated with meropenem

Exclusion Criteria:

  • eGFR(CKD-EPI) < 70ml/min/1.73m²
  • Renal replacement therapy
  • Pregnancy
  • DNR code 1-3

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
Measure Description
Time Frame
Risk factors for target non attainment
Time Frame: on day of sampling
risk factors will be assessed by comparing patients who attain target vs. those who don't
on day of sampling

Collaborators and Investigators

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

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 (Actual)

August 1, 2012

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

June 6, 2018

First Submitted That Met QC Criteria

June 6, 2018

First Posted (Actual)

June 18, 2018

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML8459

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

To be discussed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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