Pharmacokinetics in Extracorporeal Membrane Oxygenation

Study Overview
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Brief Summary
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The main purpose of the present study is to investigate the risk factors that affect drug pharmacokinetic (PK) during extracorporeal membrane oxygenation (ECMO). To advance understanding of PK variance and improve the patients outcomes during ECMO.

Detailed Description
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Ex vivo experiments for drug stability testing and ECMO circuits testing in animal models.PK studies in healthy animals and critically ill animal models with or without ECMO to define the PK alterations. Clinical PK studies in critically ill patients on ECMO.

Official Title
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Pharmacokinetics of Antibiotics, Sedative and Analgesic During Extracorporeal Membrane Oxygenation

Conditions
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Extracorporeal Membrane Oxygenation, Pharmacokinetics

Intervention / Treatment
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* Device: ECMO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are undergoing ECMO for respiratory and or cardiac dysfunction Clinical indication for the antibiotics Clinical indication for the sedatives and analgesics Exclusion Criteria: No consent Known allergy to study drug Pregnancy Massive fluid resuscitation (>50% blood volume transfused) in the previous 8 hours. Therapeutic plasma exchange in the preceding 24 hours

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Animal study<br>Critically ill animal on ECMO. PK data from critically ill animal on ECMO will be compared with data from controls and healthy animal on ECMO. | Device: ECMO<br>* Extracorporeal membrane oxygenation (ECMO) temporarily supports patients with severe cardio-respiratory failure<br>* Other names: Extracorporeal membrane oxygenation;|
| Clinical study<br>To describe variation of plasma concentration of drugs in patients receiving ECMO, as compared with patients without ECMO.And develop population PK model for ECMO patients. | Device: ECMO<br>* Extracorporeal membrane oxygenation (ECMO) temporarily supports patients with severe cardio-respiratory failure<br>* Other names: Extracorporeal membrane oxygenation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The median observed peak concentration(Cmax) | Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs | one-dose period | 
| The median observed through concentration(Cmin) | Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs | one-dose period | 
| Volume of distribution(Vd) | PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0 | one-dose period | 
| Area under the plasma concentration versus time curve (AUC) | PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0 | one-dose period | 
| Inter-compartmental clearance (Q) | PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0 | one-dose period | 
| Clearance(CL) | PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0 | one-dose period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of strategies for drug administration in critically ill patients receiving ECMO | PK models for study drugs using a non-linear mixed effects modeling approach. | one-dose period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, extracorporeal membrane oxygenation