Skip to main content
Clinical Trials/NCT03776305
NCT03776305
Unknown
Phase 4

Pharmacokinetics of Imipenem in Critically Ill Patients With Life-threatening Severe Infections During Support With Extracorporeal Membrane Oxygenation

Prince of Songkla University1 site in 1 country12 target enrollmentDecember 1, 2015

Overview

Phase
Phase 4
Intervention
Imipenem
Conditions
Critically Ill Patients With ECMO
Sponsor
Prince of Songkla University
Enrollment
12
Locations
1
Primary Endpoint
Concentration of imipenem in plasma
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2015
End Date
December 30, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sutep Jaruratanasirikul

Principle Investigator

Prince of Songkla University

Eligibility Criteria

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

Arms & Interventions

Imipenem ECMO

1-h infusion of 0.5 g of imipenem, q6h

Intervention: Imipenem

Outcomes

Primary Outcomes

Concentration of imipenem in plasma

Time Frame: 6 hour after the imipenem dose

Individual concentration of imipenem in plasma

Study Sites (1)

Loading locations...

Similar Trials