NCT03507751

Pharmacokinetics of Meropenem During High-dose CRRT

Pharmacokinetics of Meropenem During High-dose Continuous Renal Replacement Therapy in Critically Ill Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 19 (actual)
• Sponsor: Medical University of Lublin · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection
• Renal Failure

Interventions

Type	Name	Description
DRUG	Meropenem	1.0 gram of meropenem given intravenously every 8 hours
DEVICE	CRRT	Continuous renal replacement therapy for three days

Timeline

• Start date: 2018-04-02
• Primary completion: 2018-12-31
• Completion: 2019-02-02
• First posted: 2018-04-25
• Last updated: 2023-11-28

Locations

1 site across 1 country: Poland

Regulatory

• FDA-regulated drug study
• FDA-regulated device study