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

Completed

• Conditions: Extracorporeal Membrane Oxygenation Complication; Hypoxia

• Registration Number: NCT03659513
• Lead Sponsor: University of Pennsylvania

Brief 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.

Study Timeline

• Study Start: 2016-09-13
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-06
• Primary Completion: 2022-10-24
• Study Completion: 2022-10-24
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Patient with respiratory failure undergoing ECMO.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of the antibiotics - Maximal Serum Antibiotic Concentration	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)	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 Outcome Measures

Name	Time	Method
Clinical effectiveness of antibiotic dosing for ECMO patients	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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States