The Effect of ECMO on the Pharmacokinetics of the Drugs and Their Clinical Efficacy

Study Overview
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Brief Summary
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This study will examine the pharmacokinetics of the various, routinely given antibiotics, sedatives, and opioids in patients undergoing venous-venous extra-corporal oxygenation (ECMO). Little is known about the distribution and effectiveness of antibiotics in this particular patient population.

Detailed Description
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Patients with severe hypoxia that is refractory to traditional therapies are occasionally placed on venous-venous extracorporal membrane oxygenation (vv ECMO) to provide a bridge during the time when lungs alone cannot provide necessary support. This procedure is gaining prominence but it is largely unknown how medications, especially antibiotics, given to the patient on ECMO is distributed throughout the body as compared to patients without ECMO. Since the serum level of medication determines the biological activity of the drug, it is important to know if there is a difference in drug distribution between ECMO and non-ECMO patients. The investigator already collected well-established data on several antibiotics on non-ECMO as a part of FDA labeling. The study will help to determine if the concentration of currently prescribed are sufficient enough to reach their intended concentration in the study.

Official Title
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Pharmacokinetics of the Drugs and Their Biological Response in ECMO Patients

Conditions
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Hypoxia, Extracorporeal Membrane Oxygenation Complication

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with respiratory failure undergoing ECMO. Exclusion Criteria: Lack of consent Age less than 18 years old Hematocrit lower than 7

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of the antibiotics - Maximal Serum Antibiotic Concentration | The primary outcome is the data describing the Maximal Serum Antibiotic Concentration (Cmax) of the antibiotics after the onset of infusion.This will be achieved by serial measurements of the serum antibiotic levels at discrete time points for total of 24 hours after starting antibiotics. We will calculate Cmax to demonstrate maximal concentration of the antibiotics. | 24 hours | 
| Pharmacokinetics of the antibiotics - Area Under Curve (AUC) | The primary outcome is the data describing the Area Under Curve (AUC) of the antibiotics after the onset of infusion. This will be achieved by serial measurements of the serum antibiotic levels at discrete time points for total of 24 hours after starting antibiotics. We will calculate AUC to further demonstrate the distribution of antibiotic patients undergoing ECMO treatment. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical effectiveness of antibiotic dosing for ECMO patients | The investigators will correlate serum concentration of antibiotics to the resolution of infection, pressor requirements, and survival in patients. The surveillance will take place up to 3 months after the conclusion of the study protocol. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoxia, ECMO, Antibiotics, Pharmacokinetics