Prospective study to investigate meropenem serum levels in sepsis patients with and without renal replacement therapy

• Conditions: A41.9; Sepsis, unspecified

• Registration Number: DRKS00004778
• Lead Sponsor: niversitätsklinikum Jena - Klinik für Anästhesiologie und Intensivtherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-05
• Study Completion: 2015-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Sepsis, antimicrobial therapy with meropenem as indicated by the treating physician, age =18 years, in 30 patients: treatment with extended daily dialysis (n=15) or treatment with continuous hemodialysis (n=15)

Exclusion Criteria

age <18 years, pregnant or lactating women, meropenem in cerebral infections, participation in another interventional trial, other renal replacement therapy as daily extended dialysis or continuous hemodialysis, dialysis in the last 12 hours before study inclusion, acute kidney failure (creatinine clearance <80 ml/min) without indication for renal replacement therapy, no commitment for full organ support (i.e. DNR order), not expected to survive this hospital stay because of preexisting diseases, staff and their relatives

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of the area under the serum concentration-time curve (AUC) above 4fold minimal inhibitory concentration (MIC)<br>(time points of measurement of meropenem serum levels see arm 1-3)

Secondary Outcome Measures

Name	Time	Method
Course of meropenem serum levels,<br>Clinical course of infection,<br>procalcitonin, c-reactive protein, leukocytes at day 7,<br>Meropenem concentrations in urine and ultrafiltrate,<br>ICU and hospital length of stay,<br>ICU (intensive care unit) and hospital mortality