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PK/PD of the Sedatives, Analgesics and Antibiotics in Patients Receving ECMO

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ClinicalTrials.gov Identifier: NCT03787550
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Guangdong General Hospital

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, caspofunginin, voriconazole and meropenem.

Condition or disease Intervention/treatment
Drug Effect Drug: The Sedatives, analgesics and antibiotics

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Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics/Pharmacodynamics of the Sedatives, Analgesics and Antibiotics in Patients Receving Extracorporeal Membrane Oxygenation (ECMO)
Estimated Study Start Date : December 31, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. Minimum Plasma Concentration [Cmin] [ Time Frame: Up to 24 hours. ]
    The minimum plamsa concentration (the trough concentration), usually collected before the next dose.

  2. Area Under the Curve [AUC] [ Time Frame: 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.

  3. Maximum Plasma Concentration [Cmax] [ Time Frame: Up to 24 hours. ]
    The maximum plamsa concentration, usually at the end of the infusion during an dose interval.


Secondary Outcome Measures :
  1. ICU mortality [ Time Frame: 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.

  2. Hospital mortality [ Time Frame: 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.

  3. Mechanical ventilation duration [ Time Frame: Up to 60 days. ]
    Mechanical ventilation duration is the length of days the patients on the mechanical ventilation.

  4. ICU length of stay (LOS) [ Time Frame: Up to 60 days. ]
    ICU length of stay (LOS) is the length of days the patients in the ICU.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787550


Contacts
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Contact: Chunbo Chen, Ph. D. +86-20-83827812 ext 51157 gghccm@163.com
Contact: Xipei Wang, Ph. D. +86-20-83827812 ext 51157 xipei_wang@163.com

Locations
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China, Guangdong
Guangzhou First People's Hospital Not yet recruiting
Guangzhou, Guangdong, China
Nanfang Hospital Not yet recruiting
Guangzhou, Guangdong, China
Sponsors and Collaborators
Guangdong General Hospital
Investigators
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Study Chair: Chunbo Chen, Ph. D. Guandong General Hospital

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Responsible Party: Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT03787550     History of Changes
Other Study ID Numbers: ECMO001
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guangdong General Hospital:
ECMO
Sedatives
Analgesics
Antibiotics

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Analgesics
Hypnotics and Sedatives
Anti-Infective Agents
Antitubercular Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants