Imipenem in Critically Ill Patients

Prince of Songkla University

Status and phase: Unknown; Phase 4

Conditions: Critically Ill Patients With ECMO

Treatments: Drug: Imipenem

Study type: Interventional

Funder types: Other

Identifiers

NCT03776305

IMIECMO2018

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Imipenem ECMO

Experimental group

Description:

1-h infusion of 0.5 g of imipenem, q6h

Treatment:

Drug: Imipenem