Critical IllnessNCT03560557
Optimization of PK/PD Target Attainment for Meropenem in Critically Ill Patients With Sepsis
An observational study of Critical Illness and Pharmacokinetics, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
WP1.1. PK/PD target attainment: Plasma exposure, Excretion via urine \& ELF exposure; WP1.2. Predictive dosing algorithm; WP1.3. ECMO subset Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Pharmacokinetics
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Oct 2017
- 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: Critically ill patients with sepsis and receiving meropenem
Who may be able to join
- Severe sepsis or septic shock
- Admitted to an ICU ward
- Treated with meropenem
Who cannot join
- eGFR(CKD-EPI) < 70ml/min/1.73m²
- Renal replacement therapy
- Pregnancy
- DNR code 1-3
About this study
WP1.1. PK/PD target attainment: Plasma exposure, Excretion via urine \& ELF exposure; WP1.2. Predictive dosing algorithm; WP1.3. ECMO subset
Read the detailed description
First, the investigators will document exposure to meropenem in plasma and epithelial lining fluid. Moreover excretion in urine will be documented.
Second, the investigators will try to identify risk factors for not attaining PK/PD target. Based on significant predictors for target non attainment a predictive dosing algorithm will be constructed.
Finally in a small subset of ECMO patients PK exposure will be explored.
- Conditions
- Critical Illness, Pharmacokinetics
- Keywords
- Pharmacokinetics, Meropenem, Critical illness, Capillary leak, Augmented renal clearance
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors for target non attainment
risk factors will be assessed by comparing patients who attain target vs. those who don't
Measured: on day of sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study startAug 2012
- Primary completionOct 2017
- Study completionOct 2017
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 Critical IllnessStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Gijsen, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Isabel Spriet, PharmD PhD, Study director, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560557
- Sponsor's protocol ID
- ML8459
- Status last verified
- Jan 2021
- First submitted
- 6 Jun 2018
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be discussed
Publications
Gijsen M, Elkayal O, Annaert P, Van Daele R, Meersseman P, Debaveye Y, Wauters J, Dreesen E, Spriet I. Meropenem Target Attainment and Population Pharmacokinetics in Critically Ill Septic Patients with Preserved or Increased Renal Function. Infect Drug Resist. 2022 Jan 8;15:53-62. doi: 10.2147/IDR.S343264. eCollection 2022.
PubMed 35035223
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of PK/PD Target Attainment for Meropenem in Critically Ill Patients With Sepsis
- ClinicalTrials.gov ID
- NCT03560557
- Acronym / sponsor ID
- ML8459
- Conditions
- Critical Illness, Pharmacokinetics
- Keywords
- Pharmacokinetics, Meropenem, Critical illness, Capillary leak, Augmented renal clearance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 18 Jun 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.
WP1.1. PK/PD target attainment: Plasma exposure, Excretion via urine \& ELF exposure; WP1.2. Predictive dosing algorithm; WP1.3. ECMO subset
Detailed description
First, the investigators will document exposure to meropenem in plasma and epithelial lining fluid. Moreover excretion in urine will be documented.
Second, the investigators will try to identify risk factors for not attaining PK/PD target. Based on significant predictors for target non attainment a predictive dosing algorithm will be constructed.
Finally in a small subset of ECMO patients PK exposure will be explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with sepsis and receiving meropenem
Key inclusion criteria (3 listed)
- Severe sepsis or septic shock
- Admitted to an ICU ward
- Treated with meropenem
Key exclusion criteria (4 listed)
- eGFR(CKD-EPI) < 70ml/min/1.73m²
- Renal replacement therapy
- Pregnancy
- DNR code 1-3
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
Risk factors for target non attainment
Time frame: on day of sampling
risk factors will be assessed by comparing patients who attain target vs. those who don't
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 22 Jan 2021.
- Derived from this study: PubMed 35035223Gijsen M, Elkayal O, Annaert P, Van Daele R, Meersseman P, Debaveye Y, Wauters J, Dreesen E, Spriet I. Meropenem Target Attainment and Population Pharmacokinetics in Critically Ill Septic Patients with Preserved or Increased Renal Function. Infect Drug Resist. 2022 Jan 8;15:53-62. doi: 10.2147/IDR.S343264. eCollection 2022.
- Individual participant dataSharing planned: Undecided. To be discussed
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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.
Isabel Spriet, PharmD PhD study director
UZ Leuven
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Pharmacokinetics, run by Universitaire Ziekenhuizen KU Leuven.
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 4 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Risk factors for target non attainment (time frame: on day of sampling). 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 NCT03560557, 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 22 Jan 2021.