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

Hypoxia Clinical Trial

— ECMOPK  

Official title:

Pharmacokinetics of the Drugs and Their Biological Response in ECMO Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659513
• Other study ID #: 825636
• Status: Completed
• Start date: September 13, 2016
• Est. completion date: October 24, 2022

Study information

• Verified date: July 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 24, 2022
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with respiratory failure undergoing ECMO.

Exclusion Criteria:

• Lack of consent

• Age less than 18 years old

• Hematocrit lower than 7

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation Complication
• Hypoxia

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of the antibiotics - Maximal Serum Antibiotic Concentration	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.	24 hours
Primary	Pharmacokinetics of the antibiotics - Area Under Curve (AUC)	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.	24 hours
Secondary	Clinical effectiveness of antibiotic dosing for ECMO patients	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.	3 months