The Effect of ECMO on the Pharmacokinetics of the Drugs and Their Clinical Efficacy

This study will examine the pharmacokinetics of the various, routinely given antibiotics, sedatives, and opioids in patients undergoing venous-venous extra-corporal oxygenation (ECMO). Little is known about the distribution and effectiveness of antibiotics in this particular patient population.

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Key information

Conditions

Hypoxia Extracorporeal Membrane Oxygenation Complication Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

Patients with severe hypoxia that is refractory to traditional therapies are occasionally placed on venous-venous extracorporal membrane oxygenation (vv ECMO) to provide a bridge during the time when lungs alone cannot provide necessary support. This procedure is gaining prominence but it is largely unknown how medications, especially antibiotics, given to the patient on ECMO is distributed throughout the body as compared to patients without ECMO. Since the serum level of medication determines the biological activity of the drug, it is important to know if there is a difference in drug distribution between ECMO and non-ECMO patients. The investigator already collected well-established data on several antibiotics on non-ECMO as a part of FDA labeling. The study will help to determine if the concentration of currently prescribed are sufficient enough to reach their intended concentration in the study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient with respiratory failure undergoing ECMO.

Exclusion criteria

Lack of consent
Age less than 18 years old
Hematocrit lower than 7

Treatment and study plan

Primary outcomes

Pharmacokinetics of the antibiotics - Maximal Serum Antibiotic Concentration

Time frame: 24 hours

The primary outcome is the data describing the Maximal Serum Antibiotic Concentration (Cmax) of the antibiotics after the onset of infusion.This will be achieved by serial measurements of the serum antibiotic levels at discrete time points for total of 24 hours after starting antibiotics. We will calculate Cmax to demonstrate maximal concentration of the antibiotics.
Pharmacokinetics of the antibiotics - Area Under Curve (AUC)

Time frame: 24 hours

The primary outcome is the data describing the Area Under Curve (AUC) of the antibiotics after the onset of infusion. This will be achieved by serial measurements of the serum antibiotic levels at discrete time points for total of 24 hours after starting antibiotics. We will calculate AUC to further demonstrate the distribution of antibiotic patients undergoing ECMO treatment.

Secondary outcomes

Clinical effectiveness of antibiotic dosing for ECMO patients

Time frame: 3 months

The investigators will correlate serum concentration of antibiotics to the resolution of infection, pressor requirements, and survival in patients. The surveillance will take place up to 3 months after the conclusion of the study protocol.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Pharmacokinetics of the Drugs and Their Biological Response in ECMO Patients

Acronym: ECMOPK

Important dates

Study start: 2016
Primary completion: 2022
Study completion: 2022
First posted: Sep 6, 2018
Registry last updated: Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed