PK/PD of the Sedatives, Analgesics and Antibiotics in Patients Receiving ECMO

Study Overview
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Brief Summary
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It is a multi-center, open-label, observational study aimed to understand the pharmacokinetics and pharmacodynamics of the commonly used sedative, analgesic and antibiotic drugs in adult patients supported with extracorporeal membrane oxygenation (ECMO), by measuring the plasma concentrations and the clinical effect of dexmedetomidine, midazolam, butorphanol, remifentanil, sufentanil, propofol, linezolid, tigecycline, teicoplanin, caspofungin, voriconazole and meropenem.

Official Title
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Pharmacokinetics/Pharmacodynamics of the Sedatives, Analgesics and Antibiotics in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)

Conditions
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Drug Effect

Intervention / Treatment
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* Drug: The Sedatives, analgesics and antibiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient given the sedatives, analgesics and antibiotics of interest during ECMO. Age from 18 to 85 years old. Multiple blood sampling is acceptable. Exclusion Criteria: Patients who are allergic to the investigated drugs. Patients who are pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Model building group<br>The data from the patients in the model building group will be used to build the population PK/PD model. Two to six blood samples will be collected during at least one dose interval at the steady-state, including one sample from the start of ECMO and one at the end of ECMO. | Drug: The Sedatives, analgesics and antibiotics<br>* The sedatives (dexmedetomidine, midazolam, propofol), analgesics (butorphanol, remifentanil, sufentanil), and six antibiotics (linezolid, voriconazole, tigecycline, teicoplanin, caspofungin and meropenem) will be used according to the clinical need.<br>|
| Model validation group<br>The data from the patients in the model building group will be used to build the population PK/PD model. Two to three blood samples will be collected during at least one dose interval at the steady-state, including one sample from the start of ECMO and one at the end of ECMO. | Drug: The Sedatives, analgesics and antibiotics<br>* The sedatives (dexmedetomidine, midazolam, propofol), analgesics (butorphanol, remifentanil, sufentanil), and six antibiotics (linezolid, voriconazole, tigecycline, teicoplanin, caspofungin and meropenem) will be used according to the clinical need.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum Plasma Concentration [Cmin] | The minimum plasma concentration (the trough concentration), usually collected before the next dose. | Up to 24 hours. | 
| Area Under the Curve [AUC] | The area under the curve during the dose interval. It also can be calculated by the dose and the clearance of the drug. | Up to 24 hours. | 
| Maximum Plasma Concentration [Cmax] | The maximum plasma concentration, usually at the end of the infusion during an dose interval. | Up to 24 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality | The intensive care unit (ICU) mortality is calculated as the number of deaths of the enrolled patients admitted to the ICU, divided by the number of the enrolled patient discharges from the ICU (including deaths and transfers), and often presented as percentage. | Up to 60 days. | 
| Hospital mortality | The hospital mortality is calculated as the number of deaths of the enrolled patients divided by the number of the total enrolled patient, and often presented as percentage. | Up to 60 days. | 
| Mechanical ventilation duration | Mechanical ventilation duration is the length of days the patients on the mechanical ventilation. | Up to 60 days. | 
| ICU length of stay (LOS) | ICU length of stay (LOS) is the length of days the patients in the ICU. | Up to 60 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECMO, Sedatives, Analgesics, Antibiotics