NCT03787550

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 7, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

February 17, 2020

Status Verified

May 1, 2019

Enrollment Period

1.9 years

First QC Date

November 21, 2018

Last Update Submit

February 12, 2020

Conditions

Drug Effect

Keywords

ECMOSedativesAnalgesicsAntibiotics

Outcome Measures

Primary Outcomes (3)

  • 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.

Secondary Outcomes (4)

  • ICU mortality

    Up to 60 days.

  • Hospital mortality

    Up to 60 days.

  • Mechanical ventilation duration

    Up to 60 days.

  • ICU length of stay (LOS)

    Up to 60 days.

Study Arms (2)

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

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

Interventions

The Sedatives, analgesics and antibioticsDRUG

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 building groupModel validation group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patient given the sedatives, analgesics and antibiotics of interest during ECMO.
  • Age from 18 to 85 years old.
  • Multiple blood sampling is acceptable.

You may not qualify if:

  • Patients who are allergic to the investigated drugs.
  • Patients who are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Nanfang Hospital

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Interventions

AnalgesicsAnti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Sensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesAnti-Infective Agents

Study Officials

  • Chunbo Chen, Ph. D.

    Guandong General Hospital

    STUDY CHAIR

Central Study Contacts

Chunbo Chen, Ph. D.

CONTACT

+86-20-83827812gghccm@163.com

Xipei Wang, Ph. D.

CONTACT

+86-20-83827812xipei_wang@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2018

First Posted

December 26, 2018

Study Start

February 7, 2020

Primary Completion

December 31, 2021

Study Completion

March 31, 2022

Last Updated

February 17, 2020

Record last verified: 2019-05

Locations

CN(3)