Pharmacokinetics of Meropenem During High-dose CRRT

Completed

• Conditions: Renal Failure; Infection
• Interventions: Drug: Meropenem; Device: CRRT

• Registration Number: NCT03507751
• Lead Sponsor: Medical University of Lublin

Brief Summary

Assessment of meropenem plasma concentration in critically ill patients who require CRRT (continuous renal replacement therapy). A standard dose of meropenem is administered, i.e. 1 gram every 8 hours.

Detailed Description

This is a prospective observational study performed on critically ill patients. Inclusion criteria are a severe infection on admission requiring the use of meropenem and CRRT.

Both medical and surgical patients will be included. Any type of infections can be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes one-hour infusion of meropenem (1.0 gram) intravenously every 8 hours.

Blood samples (2 mL) will be collected at the 15, 30, 45, 60, 75, 90, 120, 180, 240, and 480 minutes after each dose of meropenem for 3 consecutive days. The standard arterial canula will be used to obtain samples.

30 minutes after each sample collection, blood will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.

Serum meropenem concentration will be measured by high-performance liquid chromatography.

Each patient's hemodynamic parameters will be recorded with the use of transpulmonary thermodilution technique (PICCO). Other therapies, i.e. ventilatory support, sedation, an antifungal agent will be given as required.

Study Timeline

• Study Start: 2018-04-02
• Study First Submitted: 2018-04-15
• Study First Submitted QC: 2018-04-15
• Study First Posted: 2018-04-25
• Primary Completion: 2018-12-31
• Study Completion: 2019-02-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Patients who require ICU treatment due to severe infection
• age 18-80 years
• an eligible consent obtained from the patient or his/her attendant

Exclusion Criteria

• allergy to meropenem
• lack of consent to participate in the study
• age of patients below 18 or above 80 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Meropenem	CRRT	Patients who require meropenem and CRRT during ICU (intensive care unit) stay
Meropenem	Meropenem	Patients who require meropenem and CRRT during ICU (intensive care unit) stay

Primary Outcome Measures

Name	Time	Method
Plasma concentration of meropenem	3 days

Trial Locations

Locations (1)

Oddział Kliniczny Anestezjologii i Intensywnej Terapii, Wojewódzki Szpital Specjalistyczny w Olsztynie; 🇵🇱 Olsztyn, Poland