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

Completed

• Conditions: Critical Illness; Pharmacokinetics

• Registration Number: NCT03560557
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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 Timeline

• Study Start: 2012-08
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Study First Submitted: 2018-06-06
• Study First Submitted QC: 2018-06-06
• Study First Posted: 2018-06-18
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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