Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
45 participants
INTERVENTIONAL
2022-01-15
2023-01-01
Brief Summary
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Because cefuroxime is almost exclusively excreted through the kidneys, dose reduction of cefuroxime for patients with renal impairment (eGFR\<30ml/min/1.73m2) is standard of care. No prospective evidence exists that currently guideline-recommended cefuroxime dosing regimens result in at least 50%T\>MIC in adult patients on general wards, especially not in patients with renal impairment receiving a reduced dose of cefuroxime.
Objective: To investigate whether the PK-PD target of cefuroxime (50%T\>MIC) is attained in the first 24 hours of treatment in adult patients on general wards with adequate and impaired renal function receiving regular and reduced doses of cefuroxime. Study design: Observational, prospective single center cohort study Study population: Adult patients (age ≥ 18 years) on general wards of Noordwest Ziekenhuisgroep (NWZ) receiving cefuroxime as part of standard care.
Intervention: Three venapunctures within a period of 72 hours, containing a maximum of 18ml of venous blood in total.
Main study parameters: Percentage of patients attaining the cefuroxime PK-PD target of 50%T\>MIC. This will be investigated for patients with adequate renal function receiving a regular cefuroxime dose and impaired renal function receiving a guideline recommended reduced dose.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Risks imposed by participation are considered negligible. Three venapunctures, obtaining a maximum of 18 ml venous blood are not expected to cause AEs or SAEs. Participation itself does not bring any benefit as cefuroxime treatment is part of standard care, but the group related benefit could be significant. With the results of this study, current recommended cefuroxime dosing regimens are prospectively validated or an advice to reconsider current guidelines will be obtained.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Adequate renal function
Patients with adequate renal function (egfr\>30ml/min) receiving a regular cefuroxime dose
Venapunction
Three venapunctures within a period of 72 hours, containing a maximum of 18ml of venous blood in total.
Impaired renal function
Patients with impaired renal function (egfr\<30ml/min) receiving a guideline recommended reduced dose
Venapunction
Three venapunctures within a period of 72 hours, containing a maximum of 18ml of venous blood in total.
Interventions
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Venapunction
Three venapunctures within a period of 72 hours, containing a maximum of 18ml of venous blood in total.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Admitted to a general ward of Noordwest Ziekenhuisgroep - location Alkmaar
* Informed consent is obtained
Exclusion Criteria
* Renal replacement therapy during treatment with cefuroxime
* Patients admitted to the intensive care unit (ICU)
* Severely burned patients, defined as a burned surface ≥ 10%
* Patients with cystic fibrosis
* Informed consent is not obtained
18 Years
ALL
No
Sponsors
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Noordwest Ziekenhuisgroep
OTHER
Responsible Party
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Saskia E. Zieck
Coordinating investigor
Locations
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Noordwest Ziekenhuisgroep
Alkmaar, North Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL78342.029.21
Identifier Type: -
Identifier Source: org_study_id
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