Imipenem in Critically Ill Patients

NCT03776305 | Unknown Phase 4

• 1 other identifier: IMIECMO2018
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill Patients With ECMO

Keywords

pharmacokinetic; imipenem; extracorporeal membrane oxygenation

Outcome Measures

Primary Outcomes (1)

• Concentration of imipenem in plasma

  Individual concentration of imipenem in plasma

  6 hour after the imipenem dose

Study Arms (1)

Imipenem ECMO

EXPERIMENTAL

1-h infusion of 0.5 g of imipenem, q6h

Drug: Imipenem

Interventions

Imipenem DRUG

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.

Imipenem ECMO

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age \>18 year
• Patients who diagnosed as severe sepsis
• Admitted into the ICU
• Supported with ECMO

You may not qualify if:

• Patients who pregnant
• Patients who have documented hypersensitivity to carbapenem

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

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

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Related Publications (1)

• 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.

  PMID: 32886347 DERIVED

MeSH Terms

Interventions

Imipenem

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 14, 2018
• Study Start: December 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: December 30, 2020
• Last Updated: February 15, 2019

Record last verified: 2018-12

Locations

TH (1)