Drug Monitoring in Critically Ill Patients During Extracorporeal Life Support

NCT04127305 | Unknown

• 1 other identifier: Drug Monitoring during ECMO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

About 70% of critically ill patients require antiinfective therapy. Optimal antibiotic dosing is key to improve patient survival, reduce toxic effects and minimise the emergence of bacterial resistance. There is a growing body of evidence demonstrating the existence of significant changes in pharmacokinetics (PK) in intensive care patients, particularly those with extracorporeal therapy (extracorporeal membrane oxygenation (ECMO), continuous renal replacement therapy (CRRT)). To characterize the effects of extracorporal therapy for critically ill patients, we designed a prospective pilot observational study using a drug monitoring to derive relevant effects of extracorporeal therapy and clinical patient characteristics for the treatment with meropenem, teicoplanin, linezolid, piperacillin/tazobactam, levofloxacin and acyclovir.

Conditions

Drug Monitoring of Antiinfectives in Critically Ill Patients Receiving Extracorporeal Life Support

Keywords

drug monitoring; antiinfectives; intensive care; ECMO

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of antiinfective agents

  pharmacokinetic profile of 6 antiinfectives (meropenem, teicoplanin, linezolid, piperacillin / tazobactam, levofloxacin and aciclovir) as well as other influencing factors will be constructed to assess the need for dose adjustment of antiinfective agents

  12 months

Study Arms (5)

VA ECMO

Patients will be included at the beginning of VA ECMO therapy within 24-48h after start of an antiinfective therapy

Other: No Intervention

VA EMCO + RRT

Patients with RRT will be included at the beginning of VA ECMO therapy within 24-48h after start of an antiinfective therapy

Other: No Intervention

VV ECMO

Patients will be included at the beginning of VV ECMO therapy within 24-48h after start of an antiinfective therapy

Other: No Intervention

VV ECMO + RRT

Patients with RRT will be included at the beginning of VV ECMO therapy within 24-48h after start of an antiinfective therapy

Other: No Intervention

Control

Patients will be included within 24-48h after start of an antiinfective therapy

Other: No Intervention

Interventions

No Intervention OTHER

No Intervention

Control; VA ECMO; VA EMCO + RRT; VV ECMO; VV ECMO + RRT

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

critically ill patients with extracorporeal heart or lung support and possibly CRRT

You may qualify if:

• Age \> 18
• Informed consent
• Clinical infection indicated for intravenous therapy with at least one of the following index anti-infectives: meropenem, teicoplanin, linezolid, piperacillin/tazobactam, levofloxacin and/oraciclovir
• Application of an ECLS procedure with an expected duration of at least five days

You may not qualify if:

• Pregnancy
• Massive Hemorrhage

Sponsors & Collaborators

• Goethe University: lead

Study Sites (1)

Universital Hospital Frankfurt / Main

Frankfurt am Main, Deutschland, 60529, Germany

RECRUITING

Central Study Contacts

Elisabeth H. Adam, MD

CONTACT

+496963015998; elisabeth.adam@kgu.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 12, 2019
• First Posted: October 15, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: May 31, 2022
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)