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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Model building group | 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. |
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| Model validation group | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Sedatives, analgesics and antibiotics | Drug | 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The patients undergoing ECMO will be invited to participate. At least 2-12 subjects will be enrolled to build a pharmacokineic model for each drug, and 1-4 subjects for external validation for each drug. The investigators plan to study the sedatives, analgesics and antibiotics with the initial sample size at 36 in total.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunbo Chen, Ph. D. | Contact | +86-20-83827812 | 51157 | gghccm@163.com |
| Xipei Wang, Ph. D. | Contact | +86-20-83827812 | 51157 | xipei_wang@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunbo Chen, Ph. D. | Guandong General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D000700 | Analgesics |
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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|
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. |
| Guangzhou First People's Hospital | Recruiting | Guangzhou | Guangdong | China |
| Nanfang Hospital | Recruiting | Guangzhou | Guangdong | China |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000890 | Anti-Infective Agents |