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NCT03560557 Clinical Trial

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

Critical Illness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03560557
Other study ID # ML8459
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2012
Est. completion date October 2017

Study information
Verified date January 2021
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 116
Est. completion date October 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Outcome
Type Measure Description Time frame Safety issue
Primary Risk factors for target non attainment risk factors will be assessed by comparing patients who attain target vs. those who don't on day of sampling
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