Imipenem in Critically Ill Patients

Critically Ill Patients With ECMO Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03776305
• Other study ID #: IMIECMO2018
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 1, 2015
• Est. completion date: December 30, 2020

Study information

• Verified date: December 2018
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 30, 2020
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patients With ECMO

Intervention

Drug:
• Imipenem
1-h infusion of 0.5 g of imipenem diluted in 100 mL of normal saline solution, delivered via infusion pump at a constant flow rate, every 6 h. The imipenem PK studies were carried out during administration of the fourth dose of each regimen (18-24 h after the start of the regimen). Blood samples were obtained by direct venipuncture at the following times: before (time zero) and 0.25, 0.5, 0.75, 1, 2, 3, 4, 5 and 6 h after the fourth dose of each regimen.

Locations

Country	Name	City	State
Thailand	Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University	Hat Yai	Songkla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of imipenem in plasma	Individual concentration of imipenem in plasma	6 hour after the imipenem dose