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Drug Monitoring in Critically Ill Patients During Extracorporeal Life Support

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ClinicalTrials.gov Identifier: NCT04127305
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Elisabeth H. Adam, Goethe University

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.

Condition or disease Intervention/treatment
Drug Monitoring of Antiinfectives in Critically Ill Patients Receiving Extracorporeal Life Support Other: No Intervention

Detailed Description:
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. However, 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)). Existing antiinfectivedosing regimens assume a "normal" PK; currently there are no evidence-based antiinfective dosing guidelines for critically ill patients available. The current recommendations of the Paul-Ehrlich Society and the Surviving Sepsis Campaign therefore recommend explicitly appliance of a therapeutic drug monitoring (TDM) for intensive care patients to individually adjust dosing and to avoid potential over- or underdosing. To characterize the effects of extracorporal therapy for critically ill patients, we designed a prospective pilot observational study using a drug monitoring. Six antiinfectives (meropenem, teicoplanin, linezolid, piperacillin / tazobactam, levofloxacin and aciclovir) will be investigated as index substances for the various antiinfective groups. A total of 100 patients, divided into 5 groups of 20 patients, will be examined in this study: 1. venovenous (vv)-ECMO, 2. venoarterial (va)-ECMO, 3. vv-ECMO + CRRT, 4. va-ECMO + CRRT, 5. control group. Sampling for determination of trough and peak levels of the study substances will take place during the different dosing intervals. Patients will be included at the beginning of ECMO therapy within 24-48h after start of an antiinfective therapy with at least one of the index-substances; observation period will be a total of 5 days. The collected data will be analyzed to identify covariates associated with changes in PK for the 6 different antiinfectives in critically ill patients receiving extracorporeal therapy. Using the comprehensive data set collected, the pharmacokinetic profile of the 6 antiinfectives as well as other influencing factors will be constructed to assess the need for dose adjustment of antiinfective agents in these patients. This prospective observational trial addresses the current knowledge deficiency with the aim to derive relevant effects of extracorporeal therapy and clinical patient characteristics for the treatment with meropenem, teicoplanin, linezolid, piperacillin/tazobactam, levofloxacin and acyclovir. With these relevant results, adapted dosing of antiinfectives can probably be improved in critically ill patients with extracorporeal therapy in future.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Monitoring of Antiinfectives in Critically Ill Patients Receiving Extracorporeal Life Support - a Prospective Observational Pilot Study
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 31, 2020

Group/Cohort Intervention/treatment
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
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
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
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
No Intervention

Control
Patients will be included within 24-48h after start of an antiinfective therapy
Other: No Intervention
No Intervention




Primary Outcome Measures :
  1. Plasma concentration of antiinfective agents [ Time Frame: 12 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
critically ill patients with extracorporeal heart or lung support and possibly CRRT
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnancy
  • Massive Hemorrhage

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): NCT04127305


Contacts
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Contact: Elisabeth H. Adam, MD +496963015998 elisabeth.adam@kgu.de

Locations
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Germany
Universital Hospital Frankfurt / Main Recruiting
Frankfurt am Main, Deutschland, Germany, 60529
Contact: Elisabeth H. Adam, MD         
Sponsors and Collaborators
Goethe University

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Responsible Party: Elisabeth H. Adam, Principal investigator, Goethe University
ClinicalTrials.gov Identifier: NCT04127305    
Other Study ID Numbers: Drug Monitoring during ECMO
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elisabeth H. Adam, Goethe University:
drug monitoring
antiinfectives
intensive care
ECMO
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Anti-Infective Agents