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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03560557

Enrollment

116

Registered

2018-06-18

Start date

2012-08-31

Completion date

2017-10-31

Last updated

2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Pharmacokinetics

Keywords

Pharmacokinetics, Meropenem, Critical illness, Capillary leak, Augmented renal clearance

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results