Critical IllnessECMONCT06319677
PK/PD Study of Anti-Infective Drugs in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation Treatment
An observational study of Critical Illness and Extracorporeal Membrane Oxygenation Complication, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Extracorporeal membrane pulmonary oxygenation (ECMO) may provide partial or complete support for organ replacement in patients with severe cardiopulmonary failure, buying time for further management of the primary disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- ECMO treatment
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Critically ill adult patients using one or more antimicrobial agents receiving or not receiving ECMO
Who may be able to join
- Written informed consent was obtained from the patient or family member
- Patients who are undergoing ECMO or not
- Anti-infection treatment indications
Who cannot join
- Patients under 18 years of age or pregnant
- Information on antimicrobial therapy and ECMO support is incomplete
- Presence of other circumstances that make participation in this study inappropriate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xiangya Third Hospital, Central South University
Changsha, Hunan
Jingjing Liu, Doctor, +86 0731-88618170, ivljingjing@126.com
About this study
Official title: PK/PD Study of Antibiotics in Critically Ill Patients Receiving ECMO
Extracorporeal membrane pulmonary oxygenation (ECMO) may provide partial or complete support for organ replacement in patients with severe cardiopulmonary failure, buying time for further management of the primary disease. However, ECMO may significantly alter the pharmacokinetic and pharmacodynamic profiles of critically ill patients, affecting the safety and efficacy of drug therapy. This prospective observational study aims to investigate the impact of ECMO treatment on the pharmacokinetics and pharmacodynamics of antimicrobial drugs in critically ill adult patients. Investigators intend to establish a Population Pharmacokinetic (POP PK) and Pharmacokinetic/Pharmacodynamic (PK/PD) model by prospectively collecting blood samples from patients and relevant treatment data. The primary objective is to quantitatively characterize the pharmacokinetic profiles of critically ill patients undergoing ECMO support and provide model-based recommendations for drug regimens tailored to critically ill patients.
Read the detailed description
Extracorporeal Membrane Pulmonary Oxygenation (ECMO) is a temporary life-support system used to provide partial or complete organ support for adult patients with severe cardiopulmonary failure. ECMO stabilizes the vital signs of critically ill patients, allowing time for further management of the underlying disease. Effective pharmacologic treatment of the primary condition is crucial for successful patient outcomes.
Critically ill patients often exhibit significant variability in pharmacokinetics (PK) compared to the general population. Moreover, the use of extracorporeal therapeutic techniques like ECMO introduces further variability and unpredictability in drug behavior. This can result from factors such as drug depletion within ECMO circuits, altered drug distribution volumes, and reduced drug excretion.
Sepsis and septic shock due to infections like pneumonia are life-threatening conditions frequently requiring admission to intensive care units. Timely and effective antimicrobial therapy is vital to reduce morbidity and mortality. To investigate the impact of ECMO therapy on the PK and PD of antimicrobial drugs, this prospective observational study will collect blood samples from critically ill adult patients, both those receiving ECMO treatment and those not receiving it. The study will focus on various antimicrobial agents, including imipenem, vancomycin, piperacillin/tazobactam, ceftazidime/avibactam, cefoperazone/sulbactam, cefepime, ceftriaxone, ticlopidine, linezolid, tigecycline, amikacin, gentamicin, polymyxin, voriconazole, fluconazole, caspofungin, micafungin, levofloxacin, and moxifloxacin. Data collected will be used to develop a Population Pharmacokinetic and Pharmacodynamic model based on patient demographics, laboratory results, dosing information, and blood concentration data.
- Being tested
- ECMO treatment
- Keywords
- Critical Illness, ECMO, Population Pharmacokinetics
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMO treatmentDevice
Critically ill patients were treated with ECMO while receiving antimicrobial therapy
| Study group | Role | What they receive |
|---|---|---|
| ECMO treatment group | Critically ill adult patients treated with ECMO using one or more antimicrobial agents Receives: Device: ECMO treatment | |
| Non-ECMO treatment group | Critically ill adult patients using one or more antimicrobial agents not receving ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood drug concentration
Plasma drug concentration
Measured: Samples were taken in the first 72 hours after administration according to the sampling schedule
Pharmacokinetic parameter
Area under the plasma concentration-time curve（AUC）
Measured: 24 hours after administration
Pharmacokinetic parameter
Peak Plasma Concentration (Cmax)
Measured: 12 hours after administration
Secondary outcomes (1)
Mortality at 14 and 28 days
Mortality was measured by dividing the number of subjects who died during the observation period by the total number of subjects and multiplying by 100%.
Measured: Day 30 of the patient's admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South 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
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingjing Liu, Study chair, Xiangya Third Hospital, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319677
- Sponsor's protocol ID
- Ivljingjing
- Acronym
- ECMO
- Status last verified
- Sep 2023
- First submitted
- 17 Sep 2023
- Last updated
- 20 Mar 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PK/PD Study of Antibiotics in Critically Ill Patients Receiving ECMO
- ClinicalTrials.gov ID
- NCT06319677
- Acronym / sponsor ID
- ECMO / Ivljingjing
- Keywords
- Critical Illness, ECMO, Population Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 20 Mar 2024 (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.
Extracorporeal membrane pulmonary oxygenation (ECMO) may provide partial or complete support for organ replacement in patients with severe cardiopulmonary failure, buying time for further management of the primary disease. However, ECMO may significantly alter the pharmacokinetic and pharmacodynamic profiles of critically ill patients, affecting the safety and efficacy of drug therapy. This prospective observational study aims to investigate the impact of ECMO treatment on the pharmacokinetics and pharmacodynamics of antimicrobial drugs in critically ill adult patients. Investigators intend to establish a Population Pharmacokinetic (POP PK) and Pharmacokinetic/Pharmacodynamic (PK/PD) model by prospectively collecting blood samples from patients and relevant treatment data. The primary objective is to quantitatively characterize the pharmacokinetic profiles of critically ill patients undergoing ECMO support and provide model-based recommendations for drug regimens tailored to critically ill patients.
Detailed description
Extracorporeal Membrane Pulmonary Oxygenation (ECMO) is a temporary life-support system used to provide partial or complete organ support for adult patients with severe cardiopulmonary failure. ECMO stabilizes the vital signs of critically ill patients, allowing time for further management of the underlying disease. Effective pharmacologic treatment of the primary condition is crucial for successful patient outcomes.
Critically ill patients often exhibit significant variability in pharmacokinetics (PK) compared to the general population. Moreover, the use of extracorporeal therapeutic techniques like ECMO introduces further variability and unpredictability in drug behavior. This can result from factors such as drug depletion within ECMO circuits, altered drug distribution volumes, and reduced drug excretion.
Sepsis and septic shock due to infections like pneumonia are life-threatening conditions frequently requiring admission to intensive care units. Timely and effective antimicrobial therapy is vital to reduce morbidity and mortality. To investigate the impact of ECMO therapy on the PK and PD of antimicrobial drugs, this prospective observational study will collect blood samples from critically ill adult patients, both those receiving ECMO treatment and those not receiving it. The study will focus on various antimicrobial agents, including imipenem, vancomycin, piperacillin/tazobactam, ceftazidime/avibactam, cefoperazone/sulbactam, cefepime, ceftriaxone, ticlopidine, linezolid, tigecycline, amikacin, gentamicin, polymyxin, voriconazole, fluconazole, caspofungin, micafungin, levofloxacin, and moxifloxacin. Data collected will be used to develop a Population Pharmacokinetic and Pharmacodynamic model based on patient demographics, laboratory results, dosing information, and blood concentration data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECMO treatment group | – | Device: ECMO treatmentCritically ill adult patients treated with ECMO using one or more antimicrobial agents |
| Non-ECMO treatment group | – | –Critically ill adult patients using one or more antimicrobial agents not receving ECMO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill adult patients using one or more antimicrobial agents receiving or not receiving ECMO
Key inclusion criteria (3 listed)
- Written informed consent was obtained from the patient or family member
- Patients who are undergoing ECMO or not
- Anti-infection treatment indications
Key exclusion criteria (3 listed)
- Patients under 18 years of age or pregnant
- Information on antimicrobial therapy and ECMO support is incomplete
- Presence of other circumstances that make participation in this study inappropriate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECMO treatmentCritically ill patients were treated with ECMO while receiving antimicrobial therapy | Device | ECMO treatment group |
Primary outcome
Blood drug concentration
Time frame: Samples were taken in the first 72 hours after administration according to the sampling schedule
Plasma drug concentration
Pharmacokinetic parameter
Time frame: 24 hours after administration
Area under the plasma concentration-time curve（AUC）
Pharmacokinetic parameter
Time frame: 12 hours after administration
Peak Plasma Concentration (Cmax)
1 secondary outcome
Mortality at 14 and 28 days
Time frame: Day 30 of the patient's admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 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.
Jingjing Liu study chair
Xiangya Third Hospital, Central South 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 Critical Illness and Extracorporeal Membrane Oxygenation Complication, run by The Third Xiangya Hospital of Central South University at 1 site in China.
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: opening soon, as of the sponsor's last update on 20 Mar 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingjing Liu, Doctor (+86 0731-88618170, ivljingjing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood drug concentration (time frame: Samples were taken in the first 72 hours after administration according to the sampling schedule). The study lists 3 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 20 Mar 2024.