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

NCT ID: NCT03787550

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-07

Study Completion Date

2022-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Drug Effect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

The Sedatives, analgesics and antibiotics

Intervention Type 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.

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.

The Sedatives, analgesics and antibiotics

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chunbo Chen, Ph. D.

Role: STUDY_CHAIR

Guandong General Hospital

Locations

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Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Nanfang Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunbo Chen, Ph. D.

Role: CONTACT

+86-20-83827812 ext. 51157

Xipei Wang, Ph. D.

Role: CONTACT

+86-20-83827812 ext. 51157

Facility Contacts

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Chunbo Chen, Ph.D.

Role: primary

Xipei Wang, Ph.D.

Role: backup

Other Identifiers

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ECMO001

Identifier Type: -

Identifier Source: org_study_id

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