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

NCT ID: NCT03560557

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2017-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Critical Illness Pharmacokinetics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Matthias Gijsen

PharmD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isabel Spriet, PharmD PhD

Role: STUDY_DIRECTOR

UZ Leuven

References

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Gijsen M, Elkayal O, Annaert P, Van Daele R, Meersseman P, Debaveye Y, Wauters J, Dreesen E, Spriet I. Meropenem Target Attainment and Population Pharmacokinetics in Critically Ill Septic Patients with Preserved or Increased Renal Function. Infect Drug Resist. 2022 Jan 8;15:53-62. doi: 10.2147/IDR.S343264. eCollection 2022.

Reference Type DERIVED
PMID: 35035223 (View on PubMed)

Other Identifiers

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ML8459

Identifier Type: -

Identifier Source: org_study_id

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