Critically Ill Patients With ECMOPhase 4NCT03776305
Imipenem in Critically Ill Patients
A Phase 4 study testing Imipenem in people with Critically Ill Patients With ECMO, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Extracorporeal membrane oxygenation (ECMO) has become increasingly used for lifesaving respiratory and/or cardiac failure support in critically ill patients, including those with life-threatening severe infections. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Critically Ill Patients With ECMO
- What is being tested?
- Imipenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteThailand
- Study dates
- 1 Dec 2015to 30 Dec 2020
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age >18 year
- Patients who diagnosed as severe sepsis
- Admitted into the ICU
- Supported with ECMO
Who cannot join
- Patients who pregnant
- Patients who have documented hypersensitivity to carbapenem
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: Pharmacokinetics of Imipenem in Critically Ill Patients With Life-threatening Severe Infections During Support With Extracorporeal Membrane Oxygenation
Extracorporeal membrane oxygenation (ECMO) has become increasingly used for lifesaving respiratory and/or cardiac failure support in critically ill patients, including those with life-threatening severe infections. This cardiopulmonary bypass device has been shown to enhance the profound pathophysiological changes in this patient population, resulting in an alteration of the pharmacokinetics (PK) of antimicrobial agents. The aim of this study was to determine the effect of ECMO on the PK of imipenem in critically ill patients supported by this cardiopulmonary bypass device.
Methods The study was conducted in critically ill patients with respiratory and/or cardiac failure and suspected severe nosocomial infections who were supported by ECMO. All patients received a 1-h infusion of 0.5 g of imipenem every 6 h and imipenem PK studies were carried out on the fourth dose of drug administration.
- Conditions
- Critically Ill Patients With ECMO
- Being tested
- Imipenem
- Keywords
- pharmacokinetic, imipenem, extracorporeal membrane oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImipenemDrug
1-h infusion of 0.5 g of imipenem diluted in 100 mL of normal saline solution, delivered via infusion pump at a constant flow rate, every 6 h. The imipenem PK studies were carried out during administration of the fourth dose of each regimen (18-24 h after the start of the regimen). Blood samples were obtained by direct venipuncture at the following times: before (time zero) and 0.25, 0.5, 0.75, 1, 2, 3, 4, 5 and 6 h after the fourth dose of each regimen.
| Study group | Role | What they receive |
|---|---|---|
| Imipenem ECMO | Experimental | 1-h infusion of 0.5 g of imipenem, q6h Receives: Drug: Imipenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of imipenem in plasma
Individual concentration of imipenem in plasma
Measured: 6 hour after the imipenem dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start1 Dec 2015
- Primary completion1 Feb 2018
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically Ill Patients With ECMOStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sutep Jaruratanasirikul, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776305
- Sponsor's protocol ID
- IMIECMO2018
- Status last verified
- Dec 2018
- First submitted
- 11 Dec 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Jaruratanasirikul S, Vattanavanit V, Wongpoowarak W, Nawakitrangsan M, Samaeng M. Pharmacokinetics and Monte Carlo Dosing Simulations of Imipenem in Critically Ill Patients with Life-Threatening Severe Infections During Support with Extracorporeal Membrane Oxygenation. Eur J Drug Metab Pharmacokinet. 2020 Dec;45(6):735-747. doi: 10.1007/s13318-020-00643-3.
PubMed 32886347
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Imipenem in Critically Ill Patients With Life-threatening Severe Infections During Support With Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT03776305
- Acronym / sponsor ID
- IMIECMO2018
- Conditions
- Critically Ill Patients With ECMO
- Keywords
- pharmacokinetic, imipenem, extracorporeal membrane oxygenation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 14 Dec 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.
Extracorporeal membrane oxygenation (ECMO) has become increasingly used for lifesaving respiratory and/or cardiac failure support in critically ill patients, including those with life-threatening severe infections. This cardiopulmonary bypass device has been shown to enhance the profound pathophysiological changes in this patient population, resulting in an alteration of the pharmacokinetics (PK) of antimicrobial agents. The aim of this study was to determine the effect of ECMO on the PK of imipenem in critically ill patients supported by this cardiopulmonary bypass device.
Methods The study was conducted in critically ill patients with respiratory and/or cardiac failure and suspected severe nosocomial infections who were supported by ECMO. All patients received a 1-h infusion of 0.5 g of imipenem every 6 h and imipenem PK studies were carried out on the fourth dose of drug administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imipenem ECMO | Experimental | Drug: Imipenem1-h infusion of 0.5 g of imipenem, q6h |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient age >18 year
- Patients who diagnosed as severe sepsis
- Admitted into the ICU
- Supported with ECMO
Key exclusion criteria (2 listed)
- Patients who pregnant
- Patients who have documented hypersensitivity to carbapenem
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 |
|---|---|---|
| Imipenem1-h infusion of 0.5 g of imipenem diluted in 100 mL of normal saline solution, delivered via infusion pump at a constant flow rate, every 6 h. The imipenem PK studies were carried out during administration of the fourth dose of each regimen (18-24 h after the start of the regimen). Blood samples were obtained by direct venipuncture at the following times: before (time zero) and 0.25, 0.5, 0.75, 1, 2, 3, 4, 5 and 6 h after the fourth dose of each regimen. | Drug | Imipenem ECMO |
Primary outcome
Concentration of imipenem in plasma
Time frame: 6 hour after the imipenem dose
Individual concentration of imipenem in plasma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 32886347Jaruratanasirikul S, Vattanavanit V, Wongpoowarak W, Nawakitrangsan M, Samaeng M. Pharmacokinetics and Monte Carlo Dosing Simulations of Imipenem in Critically Ill Patients with Life-Threatening Severe Infections During Support with Extracorporeal Membrane Oxygenation. Eur J Drug Metab Pharmacokinet. 2020 Dec;45(6):735-747. doi: 10.1007/s13318-020-00643-3.
Related trials for Critically Ill Patients With ECMO
RecruitingObservational study
Factors Influencing Outcomes in ECMO and Impella Patients: Metabolic and Thyroid Hormone Dynamics
Cardiogenic Shock, Euthyroid Sick Syndrome
Not yet recruitingObservational study
Extracorporeal Therapy and Therapeutic Drug Monitoring
ICU Patients With ECMO And-or RRT and With Gram Negative Infections Susceptible to BL-BLIs
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Imipenem in people with Critically Ill Patients With ECMO, run by Prince of Songkla University at 1 site in Thailand.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Feb 2019. 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 Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Concentration of imipenem in plasma (time frame: 6 hour after the imipenem dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03776305, which also lists 1 linked publication.
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 15 Feb 2019.