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Imipenem in Critically Ill Patients

Phase 4
Conditions
Critically Ill Patients With ECMO
Interventions
Registration Number
NCT03776305
Lead Sponsor
Prince of Songkla University
Brief Summary

Extracorporeal membrane oxygenation (ECMO) has become increasingly used for lifesaving respiratory and/or cardiac failure support in critically ill patients, including those with life-threatening severe infections. This cardiopulmonary bypass device has been shown to enhance the profound pathophysiological changes in this patient population, resulting in an alteration of the pharmacokinetics (PK) of antimicrobial agents. The aim of this study was to determine the effect of ECMO on the PK of imipenem in critically ill patients supported by this cardiopulmonary bypass device.

Methods The study was conducted in critically ill patients with respiratory and/or cardiac failure and suspected severe nosocomial infections who were supported by ECMO. All patients received a 1-h infusion of 0.5 g of imipenem every 6 h and imipenem PK studies were carried out on the fourth dose of drug administration.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
12
Inclusion Criteria
  • Patient age >18 year
  • Patients who diagnosed as severe sepsis
  • Admitted into the ICU
  • Supported with ECMO
Exclusion Criteria
  • Patients who pregnant
  • Patients who have documented hypersensitivity to carbapenem

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Imipenem ECMOImipenem1-h infusion of 0.5 g of imipenem, q6h
Primary Outcome Measures
NameTimeMethod
Concentration of imipenem in plasma6 hour after the imipenem dose

Individual concentration of imipenem in plasma

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University

🇹🇭

Hat Yai, Songkla, Thailand

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