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

Pharmacokinetics/Pharmacodynamics of the Sedatives, Analgesics and Antibiotics in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)

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.

Study Overview

• Status: Unknown
• Conditions: Drug Effect
• Intervention / Treatment: Drug: The Sedatives, analgesics and antibiotics

• Study Type: Observational
• Enrollment (Anticipated): 36

Contacts and Locations

• Study Contact: Name: Chunbo Chen, Ph. D.; Phone Number: 51157 +86-20-83827812; Email: gghccm@163.com
• Study Contact Backup: Name: Xipei Wang, Ph. D.; Phone Number: 51157 +86-20-83827812; Email: xipei_wang@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Contact: Chunbo Chen, Ph.D.
      • Contact: Xipei Wang, Ph.D.; Email: xipei_wang@163.com
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangzhou First People's Hospital
    • Guangzhou, Guangdong, China
      • Recruiting
      • Nanfang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 60 days.
Mechanical ventilation duration	Mechanical ventilation duration is the length of days the patients on the mechanical ventilation.	Up to 60 days.
ICU length of stay (LOS)	ICU length of stay (LOS) is the length of days the patients in the ICU.	Up to 60 days.

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Study Chair: Chunbo Chen, Ph. D., Guandong General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 7, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: December 23, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Antibiotics; ECMO; Analgesics; Sedatives
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anti-Bacterial Agents; Analgesics; Hypnotics and Sedatives
• Other Study ID Numbers: ECMO001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No