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Imipenem in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT03776305
Recruitment Status : Unknown
Verified December 2018 by Sutep Jaruratanasirikul, Prince of Songkla University.
Recruitment status was:  Active, not recruiting
First Posted : December 14, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sutep Jaruratanasirikul, Prince of Songkla University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 1, 2015
Actual Primary Completion Date : February 1, 2018
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Imipenem

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Concentration of imipenem in plasma [ Time Frame: 6 hour after the imipenem dose ]
    Individual concentration of imipenem in plasma


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776305


Locations
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Thailand
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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sutep Jaruratanasirikul, Principle Investigator, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT03776305    
Other Study ID Numbers: IMIECMO2018
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: December 2018
Keywords provided by Sutep Jaruratanasirikul, Prince of Songkla University:
pharmacokinetic
imipenem
extracorporeal membrane oxygenation
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
 Imipenem
Anti-Bacterial Agents
Anti-Infective Agents