Drug Effect
Conditions
Keywords
ECMO, Sedatives, Analgesics, Antibiotics
Brief summary
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.
Interventions
DRUGThe Sedatives, analgesics and antibiotics
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.
Sponsors
Guangdong Provincial People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimum Plasma Concentration [Cmin] | Up to 24 hours. | The minimum plasma concentration (the trough concentration), usually collected before the next dose. |
| Area Under the Curve [AUC] | Up to 24 hours. | The area under the curve during the dose interval. It also can be calculated by the dose and the clearance of the drug. |
| Maximum Plasma Concentration [Cmax] | Up to 24 hours. | The maximum plasma concentration, usually at the end of the infusion during an dose interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU mortality | Up to 60 days. | 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. |
| ICU length of stay (LOS) | Up to 60 days. | ICU length of stay (LOS) is the length of days the patients in the ICU. |
| Hospital mortality | Up to 60 days. | 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. |
| Mechanical ventilation duration | Up to 60 days. | Mechanical ventilation duration is the length of days the patients on the mechanical ventilation. |
Countries
China
Contacts
Primary ContactChunbo Chen, Ph. D.
Backup ContactXipei Wang, Ph. D.
Outcome results
None listed