The Effect of ECMO on the Pharmacokinetics of the Drugs and Their Clinical Efficacy
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2019 |
| Start Date: | September 13, 2016 |
| End Date: | December 2021 |
| Contact: | Krzysztof laudanski, MD, PhD, MA |
| Email: | klaudanski@gmail.com |
Pharmacokinetics of the Drugs and Their Biological Response in ECMO Patients
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.
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.
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.
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.
Inclusion Criteria:
- Patient with respiratory failure undergoing ECMO.
Exclusion Criteria:
- Lack of consent
- Age less than 18 years old
- Hematocrit lower than 7
We found this trial at
1
site
3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Krzysztof Laudanski, MD, PhD, MA
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