InfectionNCT03507751
Pharmacokinetics of Meropenem During High-dose CRRT
An observational study of Infection and Renal Failure, run by Medical University of Lublin at 1 site in Poland.
Trial summary
Assessment of meropenem plasma concentration in critically ill patients who require CRRT (continuous renal replacement therapy). A standard dose of meropenem is administered, i.e. 1 gram every 8 hours. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Infection, Renal Failure
- What is being tested?
- Meropenem and CRRT
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 19 participants
- Where
- 1 sitePoland
- Study dates
- 2 Apr 2018to 2 Feb 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Severely ill patients treated in ICU
Who may be able to join
- Patients who require ICU treatment due to severe infection
- age 18-80 years
- an eligible consent obtained from the patient or his/her attendant
Who cannot join
- allergy to meropenem
- lack of consent to participate in the study
- age of patients below 18 or above 80 years
Trial locations and contacts
1 site in 1 country.
Poland1 site
Oddział Kliniczny Anestezjologii i Intensywnej Terapii, Wojewódzki Szpital Specjalistyczny w Olsztynie
Olsztyn, 10- 561
About this study
Official title: Pharmacokinetics of Meropenem During High-dose Continuous Renal Replacement Therapy in Critically Ill Patients
Assessment of meropenem plasma concentration in critically ill patients who require CRRT (continuous renal replacement therapy). A standard dose of meropenem is administered, i.e. 1 gram every 8 hours.
Read the detailed description
This is a prospective observational study performed on critically ill patients. Inclusion criteria are a severe infection on admission requiring the use of meropenem and CRRT.
Both medical and surgical patients will be included. Any type of infections can be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes one-hour infusion of meropenem (1.0 gram) intravenously every 8 hours.
Blood samples (2 mL) will be collected at the 15, 30, 45, 60, 75, 90, 120, 180, 240, and 480 minutes after each dose of meropenem for 3 consecutive days. The standard arterial canula will be used to obtain samples.
30 minutes after each sample collection, blood will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.
Serum meropenem concentration will be measured by high-performance liquid chromatography.
Each patient's hemodynamic parameters will be recorded with the use of transpulmonary thermodilution technique (PICCO). Other therapies, i.e. ventilatory support, sedation, an antifungal agent will be given as required.
- Conditions
- Infection, Renal Failure
- Being tested
- Meropenem, CRRT
- Medical subject headings
- Infections, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeropenemDrug
1.0 gram of meropenem given intravenously every 8 hours
CRRTDevice
Continuous renal replacement therapy for three days
| Study group | Role | What they receive |
|---|---|---|
| Meropenem | Patients who require meropenem and CRRT during ICU (intensive care unit) stay Receives: Drug: Meropenem; Device: CRRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of meropenem
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start2 Apr 2018
- Primary completion31 Dec 2018
- Study completion2 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warmia and Mazury in Olsztyn
- Responsible party
- Principal investigator, Michał Borys, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507751
- Sponsor's protocol ID
- 90/2009/IV
- Status last verified
- Nov 2023
- First submitted
- 15 Apr 2018
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Meropenem During High-dose Continuous Renal Replacement Therapy in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03507751
- Acronym / sponsor ID
- 90/2009/IV
- Conditions
- Infection, Renal Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Collaborators
- University of Warmia and Mazury in Olsztyn
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 2 Feb 2019 (actual)
- First posted
- 25 Apr 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.
Assessment of meropenem plasma concentration in critically ill patients who require CRRT (continuous renal replacement therapy). A standard dose of meropenem is administered, i.e. 1 gram every 8 hours.
Detailed description
This is a prospective observational study performed on critically ill patients. Inclusion criteria are a severe infection on admission requiring the use of meropenem and CRRT.
Both medical and surgical patients will be included. Any type of infections can be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes one-hour infusion of meropenem (1.0 gram) intravenously every 8 hours.
Blood samples (2 mL) will be collected at the 15, 30, 45, 60, 75, 90, 120, 180, 240, and 480 minutes after each dose of meropenem for 3 consecutive days. The standard arterial canula will be used to obtain samples.
30 minutes after each sample collection, blood will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.
Serum meropenem concentration will be measured by high-performance liquid chromatography.
Each patient's hemodynamic parameters will be recorded with the use of transpulmonary thermodilution technique (PICCO). Other therapies, i.e. ventilatory support, sedation, an antifungal agent will be given as required.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meropenem | – | Drug: Meropenem, Device: CRRTPatients who require meropenem and CRRT during ICU (intensive care unit) stay |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severely ill patients treated in ICU
Key inclusion criteria (3 listed)
- Patients who require ICU treatment due to severe infection
- age 18-80 years
- an eligible consent obtained from the patient or his/her attendant
Key exclusion criteria (3 listed)
- allergy to meropenem
- lack of consent to participate in the study
- age of patients below 18 or above 80 years
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 |
|---|---|---|
| Meropenem1.0 gram of meropenem given intravenously every 8 hours | Drug | Meropenem |
| CRRTContinuous renal replacement therapy for three days | Device | Meropenem |
Primary outcome
Plasma concentration of meropenem
Time frame: 3 days
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 28 Nov 2023.
- 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.
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?
An observational study of Infection and Renal Failure, run by Medical University of Lublin at 1 site in Poland.
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: finished, as of the sponsor's last update on 28 Nov 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 Poland. 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?
Plasma concentration of meropenem (time frame: 3 days). 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 28 Nov 2023.