NCT03659513

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

Pharmacokinetics of the Drugs and Their Biological Response in ECMO Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hypoxia
• Extracorporeal Membrane Oxygenation Complication

Timeline

• Start date: 2016-09-13
• Primary completion: 2022-10-24
• Completion: 2022-10-24
• First posted: 2018-09-06
• Last updated: 2023-07-27

Locations

1 site across 1 country: United States