Pharmacokinetics of the Drugs and Their Biological Response in ECMO Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypoxia
- Sponsor
- University of Pennsylvania
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics of the antibiotics - Maximal Serum Antibiotic Concentration
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient with respiratory failure undergoing ECMO.
Exclusion Criteria
- •Lack of consent
- •Age less than 18 years old
- •Hematocrit lower than 7
Outcomes
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(3 months)