Acute Respiratory Failure With HypoxiaNCT03467854
PK of Piperacillin/Tazobactam in Adults Undergoing ECMO
An observational study of Acute Respiratory Failure With Hypoxia, run by Columbia University at 1 site in United States.
Trial summary
This study is designed to provide preliminary data to determine if concentrations of piperacillin/tazobactam change in patients with severe respiratory failure receiving extracorporeal membrane oxygenation (ECMO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure With Hypoxia
- Type of treatment
- Injection or infusion
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 24 Sep 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients receiving VV ECMO for acute respiratory distress syndrome will be assessed for inclusion into the study.
Who may be able to join
- Patients 18 years of age or older
- Initiated on VV ECMO for acute respiratory distress syndrome
- Receiving piperacillin/tazobactam
Who cannot join
- Pregnancy
- Massive blood transfusion (10 units or more of of PRBC) within a 24-hour period
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, 10032
About this study
Official title: Pharmacokinetics (PK) of Piperacillin/Tazobactam in Adults Undergoing Extracorporeal Membrane Oxygenation (ECMO)
This study is designed to provide preliminary data to determine if concentrations of piperacillin/tazobactam change in patients with severe respiratory failure receiving extracorporeal membrane oxygenation (ECMO). The investigators hypothesize that patients will have significant changes in concentration measurements, specifically an increased clearance rate and increased volume of distribution, during ECMO as compared to critically ill patients.
Read the detailed description
In a healthy patient, the lungs provide oxygen to the blood and remove carbon dioxide. However, in patients with severe lung failure, blood may not adequately be delivered to the lungs, or the lungs may not adequately supply blood with oxygen. In this case, patients may require assistance from a machine to help provide this oxygen. Extracorporeal membrane oxygenation (ECMO) is a device that acts as an artificial lung, allowing the patient to recover from their illness. Patients receiving support from ECMO are often put in a medically induced coma while their lungs heal. Certain drugs may stick to the internal surfaces of the machine; therefore leading to decreased concentrations. Patients receiving ECMO often require antimicrobials to treat severe infections. However, little data exist concerning the likely changes in drug concentrations from drug circuit interactions in adult patients receiving ECMO.
- Conditions
- Acute Respiratory Failure With Hypoxia
- Keywords
- ECMO, Antimicrobials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VV ECMO | Patients 18 years of age or older, initiated on veno-venous (VV) ECMO for acute respiratory distress syndrome, and receiving piperacillin/tazobactam.Four blood samples will be obtained after the first dose of piperacillin/tazobactam: one sample before the second dose, 30-minutes, 2-hours, and 6-hours into the infusion. An additional four blood samples will be drawn on day 2 at the same time points. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clearance rate
Measured: Up to 2 days after the first dose of piperacillin/tazobactam
Change in volume of distribution
Measured: Up to 2 days after the first dose of piperacillin/tazobactam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Jan 2019
- Primary completion24 Sep 2024
- Study completion24 Sep 2024
Why it stopped: Lack or eligible patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Failure With HypoxiaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darryl Abrams, Columbia University
- Investigators
- Darryl Abrams, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467854
- Sponsor's protocol ID
- AAAR7200
- Status last verified
- Sep 2024
- First submitted
- 10 Mar 2018
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics (PK) of Piperacillin/Tazobactam in Adults Undergoing Extracorporeal Membrane Oxygenation (ECMO)
- ClinicalTrials.gov ID
- NCT03467854
- Acronym / sponsor ID
- AAAR7200
- Conditions
- Acute Respiratory Failure With Hypoxia
- Keywords
- ECMO, Antimicrobials
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack or eligible patients.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 16 Mar 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 is designed to provide preliminary data to determine if concentrations of piperacillin/tazobactam change in patients with severe respiratory failure receiving extracorporeal membrane oxygenation (ECMO). The investigators hypothesize that patients will have significant changes in concentration measurements, specifically an increased clearance rate and increased volume of distribution, during ECMO as compared to critically ill patients.
Detailed description
In a healthy patient, the lungs provide oxygen to the blood and remove carbon dioxide. However, in patients with severe lung failure, blood may not adequately be delivered to the lungs, or the lungs may not adequately supply blood with oxygen. In this case, patients may require assistance from a machine to help provide this oxygen. Extracorporeal membrane oxygenation (ECMO) is a device that acts as an artificial lung, allowing the patient to recover from their illness. Patients receiving support from ECMO are often put in a medically induced coma while their lungs heal. Certain drugs may stick to the internal surfaces of the machine; therefore leading to decreased concentrations. Patients receiving ECMO often require antimicrobials to treat severe infections. However, little data exist concerning the likely changes in drug concentrations from drug circuit interactions in adult patients receiving ECMO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VV ECMO | – | –Patients 18 years of age or older, initiated on veno-venous (VV) ECMO for acute respiratory distress syndrome, and receiving piperacillin/tazobactam.Four blood samples will be obtained after the first dose of piperacillin/tazobactam: one sample before the second dose, 30-minutes, 2-hours, and 6-hours into the infusion. An additional four blood samples will be drawn on day 2 at the same time points. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients receiving VV ECMO for acute respiratory distress syndrome will be assessed for inclusion into the study.
Key inclusion criteria (3 listed)
- Patients 18 years of age or older
- Initiated on VV ECMO for acute respiratory distress syndrome
- Receiving piperacillin/tazobactam
Key exclusion criteria (3 listed)
- Pregnancy
- Massive blood transfusion (10 units or more of of PRBC) within a 24-hour period
- Prisoners
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
Change in clearance rate
Time frame: Up to 2 days after the first dose of piperacillin/tazobactam
Change in volume of distribution
Time frame: Up to 2 days after the first dose of piperacillin/tazobactam
Results and safety
The study was stopped early (reason given: Lack or eligible patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Darryl Abrams, MD principal investigator
Columbia University
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 Acute Respiratory Failure With Hypoxia, run by Columbia University 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 3 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: stopped early, as of the sponsor's last update on 26 Sep 2024. 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 was stopped early (reason given: Lack or eligible patients.). Results are not available in the source record.
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?
Change in clearance rate (time frame: Up to 2 days after the first dose of piperacillin/tazobactam). 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 26 Sep 2024.