Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-25 @ 4:24 PM
Study NCT ID:
NCT03560557
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2018-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimization of PK/PD Target Attainment for Meropenem in Critically Ill Patients With Sepsis
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Study Overview
Official Title:
Optimization of PK/PD Target Attainment for Meropenem in Critically Ill Patients With Sepsis
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: