Imipenem in Critically Ill Patients

• Sponsor: Prince of Songkla University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03776305
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 61
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critically Ill Patients With ECMO	Drug: Imipenem	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetics of Imipenem in Critically Ill Patients With Life-threatening Severe Infections During Support With Extracorporeal Membrane Oxygenation
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Feb 1, 2018
• Anticipated Study Completion Date: Dec 30, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Imipenem ECMO 1-h infusion of 0.5 g of imipenem, q6h

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.

Outcome Measures

Primary Outcome Measures

1. Concentration of imipenem in plasma [6 hour after the imipenem dose]

   Individual concentration of imipenem in plasma

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University	Hat Yai	Songkla	Thailand	90110

Sponsors and Collaborators

• Prince of Songkla University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sutep Jaruratanasirikul, Principle Investigator, Prince of Songkla University
• ClinicalTrials.gov Identifier: NCT03776305
• Other Study ID Numbers: IMIECMO2018
• First Posted: Dec 14, 2018
• Last Update Posted: Feb 15, 2019
• Last Verified: Dec 1, 2018

• Keywords provided by Sutep Jaruratanasirikul, Principle Investigator, Prince of Songkla University: pharmacokinetic; imipenem; extracorporeal membrane oxygenation
• Additional relevant MeSH terms: Critical Illness; Imipenem

Study Results

No Results Posted as of Feb 15, 2019