SepsisABC2NCT04203784
Meropenem and Piperacillin Plasma Concentrations During CRRT
An observational study of Sepsis and Infection, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
This observational study reports meropenem and piperacillin plasma concentrations in patients treated with either antibiotic and simultaneous continuous renal replacement therapy (CRRT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Infection, Antibiotic
- What is being tested?
- Plasma concentration measurements
- How many people
- 135 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2012to 31 Dec 2016
- 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
- Adult, Older adult
Study population: ICU patients
Who may be able to join
- patients treated in the study ICU and
- simultaneous CRRT and antibiotic treatment with either meropenem or piperacillin-tazobactam.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
This observational study reports meropenem and piperacillin plasma concentrations in patients treated with either antibiotic and simultaneous continuous renal replacement therapy (CRRT).
- Conditions
- Sepsis, Infection, Antibiotic, Renal Replacement Therapy, Hemolysis
- Being tested
- Plasma concentration measurements
- Medical subject headings
- Sepsis, Infections, Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma concentration measurementsOther
Plasma concentration measurements
| Study group | Role | What they receive |
|---|---|---|
| Meropenem treated patients | Not described Receives: Other: Plasma concentration measurements | |
| Piperacillin treated patients | Not described Receives: Other: Plasma concentration measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma antibiotic concentrations at mid and end of dosing interval
We vill report the measured plasma antibiotic concentrations at the mid and end of the dosing interval.
Measured: 1 week
Plasma antibiotic concentrations at mid and end of dosing interval
The percentage of patients having a concentration above the highest MIC (minimal inhibitory concentration) breakpoint for pathogens considered susceptible for the antibiotic.
Measured: 1 week
Relationships between plasma antibiotic concentrations and CRRT dose.
We will report the correlation between measured plasma concentrations of either antibiotic and the intensity of the CRRT treatment.
Measured: 1 week
Influence of residual diuresis on the measured plasma antibiotic concentrations.
We will report the correlation between measured plasma concentrations of either antibiotic and residual diuresis.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Nov 2012
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Petersson, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203784
- Sponsor's protocol ID
- K 2019-9604
- Acronym
- ABC2
- Status last verified
- Dec 2019
- First submitted
- 3 Nov 2019
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meropenem and Piperacillin Plasma Concentrations During CRRT
- ClinicalTrials.gov ID
- NCT04203784
- Acronym / sponsor ID
- ABC2 / K 2019-9604
- Conditions
- Sepsis, Infection, Antibiotic, Renal Replacement Therapy, Hemolysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2012 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 18 Dec 2019 (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 observational study reports meropenem and piperacillin plasma concentrations in patients treated with either antibiotic and simultaneous continuous renal replacement therapy (CRRT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meropenem treated patients | – | Other: Plasma concentration measurements |
| Piperacillin treated patients | – | Other: Plasma concentration measurements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- ICU patients
Key inclusion criteria (2 listed)
- patients treated in the study ICU and
- simultaneous CRRT and antibiotic treatment with either meropenem or piperacillin-tazobactam.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Plasma concentration measurementsPlasma concentration measurements | Other | Meropenem treated patients, Piperacillin treated patients |
Primary outcome
Plasma antibiotic concentrations at mid and end of dosing interval
Time frame: 1 week
We vill report the measured plasma antibiotic concentrations at the mid and end of the dosing interval.
Plasma antibiotic concentrations at mid and end of dosing interval
Time frame: 1 week
The percentage of patients having a concentration above the highest MIC (minimal inhibitory concentration) breakpoint for pathogens considered susceptible for the antibiotic.
Relationships between plasma antibiotic concentrations and CRRT dose.
Time frame: 1 week
We will report the correlation between measured plasma concentrations of either antibiotic and the intensity of the CRRT treatment.
Influence of residual diuresis on the measured plasma antibiotic concentrations.
Time frame: 1 week
We will report the correlation between measured plasma concentrations of either antibiotic and residual diuresis.
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 19 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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 Sepsis and Infection, run by Karolinska University Hospital at 1 site in Sweden.
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 2 inclusion and 1 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 19 Dec 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 Sweden. 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 antibiotic concentrations at mid and end of dosing interval (time frame: 1 week). The study lists 4 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 19 Dec 2019.