An observational study in Drug Effect, sponsored by Guangdong Provincial People's Hospital. Status unknown at 3 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-02-17.
Sponsored by Guangdong Provincial People's Hospital · Observational
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.
Guangdong Provincial People's Hospital is the lead sponsor of 231 studies on the registry; 101 are open to participants now.
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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.
Exclusion Criteria:
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
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
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.
Minimum Plasma Concentration [Cmin]
The minimum plasma concentration (the trough concentration), usually collected before the next dose.
Time frame: 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.
Time frame: Up to 24 hours.
Maximum Plasma Concentration [Cmax]
The maximum plasma concentration, usually at the end of the infusion during an dose interval.
Time frame: Up to 24 hours.
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.
Time frame: 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.
Time frame: Up to 60 days.
Mechanical ventilation duration
Mechanical ventilation duration is the length of days the patients on the mechanical ventilation.
Time frame: Up to 60 days.
ICU length of stay (LOS)
ICU length of stay (LOS) is the length of days the patients in the ICU.
Time frame: Up to 60 days.
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Guangdong Provincial People's Hospital