HypoxiaECMOPKNCT03659513
The Effect of ECMO on the Pharmacokinetics of the Drugs and Their Clinical Efficacy
An observational study of Hypoxia and Extracorporeal Membrane Oxygenation Complication, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Extracorporeal Membrane Oxygenation Complication
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2016to 24 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients undergoing ECMO will be invited to participate. In order to determine pharmacokinetics of the drugs, the investgators need at least 10-15 subjects in order to create a pharmacological model. Since the site plan to study 3 antibiotics, propofol and hydromorphone, the investigators calculated the initial sample size at 50
Who may be able to join
- Patient with respiratory failure undergoing ECMO.
Who cannot join
- Lack of consent
- Age less than 18 years old
- Hematocrit lower than 7
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Keywords
- Hypoxia, ECMO, Antibiotics, Pharmacokinetics
- Medical subject headings
- Hypoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
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.
Measured: 24 hours
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start13 Sep 2016
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob Gutsche, MD, Principal investigator, University of PennsylvaniaKrzysztof Laudanski, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659513
- Sponsor's protocol ID
- 825636
- Acronym
- ECMOPK
- Status last verified
- Jul 2023
- First submitted
- 15 Mar 2018
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of the Drugs and Their Biological Response in ECMO Patients
- ClinicalTrials.gov ID
- NCT03659513
- Acronym / sponsor ID
- ECMOPK / 825636
- Keywords
- Hypoxia, ECMO, Antibiotics, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 13 Sep 2016 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing ECMO will be invited to participate. In order to determine pharmacokinetics of the drugs, the investgators need at least 10-15 subjects in order to create a pharmacological model. Since the site plan to study 3 antibiotics, propofol and hydromorphone, the investigators calculated the initial sample size at 50
Key inclusion criteria (1 listed)
- Patient with respiratory failure undergoing ECMO.
Key exclusion criteria (3 listed)
- Lack of consent
- Age less than 18 years old
- Hematocrit lower than 7
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Clinical effectiveness of antibiotic dosing for ECMO patients
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Gutsche, MD principal investigator
University of Pennsylvania
Krzysztof Laudanski, MD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia and Extracorporeal Membrane Oxygenation Complication, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of the antibiotics - Maximal Serum Antibiotic Concentration (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.