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Clinical Trials/NCT03560557
NCT03560557CompletedNot Applicable

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

Universitaire Ziekenhuizen KU Leuven0 sites116 target enrollmentStarted: August 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
116
Primary Endpoint
Risk factors for target non attainment

Study Overview

Brief Summary

WP1.1. PK/PD target attainment: Plasma exposure, Excretion via urine & ELF exposure; WP1.2. Predictive dosing algorithm; WP1.3. ECMO subset

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Matthias Gijsen

PharmD

Universitaire Ziekenhuizen KU Leuven

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