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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Animal study | 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. |
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| Clinical study | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECMO | Device | Extracorporeal membrane oxygenation (ECMO) temporarily supports patients with severe cardio-respiratory failure |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are undergoing ECMO
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingyuan Zhan, MD | Contact | 13683598417 | zhanqy0915@163.com | |
| Min Li, MD | Contact | 13683598417 | qlyy_limin@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chen Wang | China-Japan Friendship Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship hospital | Recruiting | Beijing | Beijing Municipality | 100028 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32816724 | Derived | Wang Q, Zhang Z, Liu D, Chen W, Cui G, Li P, Zhang X, Li M, Zhan Q, Wang C. Population Pharmacokinetics of Caspofungin among Extracorporeal Membrane Oxygenation Patients during the Postoperative Period of Lung Transplantation. Antimicrob Agents Chemother. 2020 Oct 20;64(11):e00687-20. doi: 10.1128/AAC.00687-20. Print 2020 Oct 20. |
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| ID | Term |
|---|---|
| D015199 | Extracorporeal Membrane Oxygenation |
| ID | Term |
|---|---|
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
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Blood samples drawn from an existing arterial line and collect in 2-4ml tubes. Centrifuged at 3000 rpm for 10 minutes before frozen at -80℃.
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