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Imipenem in Critically Ill Patients

Primary Purpose

Critically Ill Patients With ECMO

Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Imipenem
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill Patients With ECMO focused on measuring pharmacokinetic, imipenem, extracorporeal membrane oxygenation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imipenem ECMO

Arm Description

1-h infusion of 0.5 g of imipenem, q6h

Outcomes

Primary Outcome Measures

Concentration of imipenem in plasma
Individual concentration of imipenem in plasma

Secondary Outcome Measures

Full Information

First Posted
December 11, 2018
Last Updated
February 13, 2019
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT03776305
Brief Title
Imipenem in Critically Ill Patients
Official Title
Pharmacokinetics of Imipenem in Critically Ill Patients With Life-threatening Severe Infections During Support With Extracorporeal Membrane Oxygenation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill Patients With ECMO
Keywords
pharmacokinetic, imipenem, extracorporeal membrane oxygenation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imipenem ECMO
Arm Type
Experimental
Arm Description
1-h infusion of 0.5 g of imipenem, q6h
Intervention Type
Drug
Intervention Name(s)
Imipenem
Intervention Description
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.
Primary Outcome Measure Information:
Title
Concentration of imipenem in plasma
Description
Individual concentration of imipenem in plasma
Time Frame
6 hour after the imipenem dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
City
Hat Yai
State/Province
Songkla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
32886347
Citation
Jaruratanasirikul S, Vattanavanit V, Wongpoowarak W, Nawakitrangsan M, Samaeng M. Pharmacokinetics and Monte Carlo Dosing Simulations of Imipenem in Critically Ill Patients with Life-Threatening Severe Infections During Support with Extracorporeal Membrane Oxygenation. Eur J Drug Metab Pharmacokinet. 2020 Dec;45(6):735-747. doi: 10.1007/s13318-020-00643-3.
Results Reference
derived

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Imipenem in Critically Ill Patients

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