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OpenTrials
Completed

NCT Number: NCT03560557

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

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

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Pharmacokinetics

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jun 18, 2018
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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