2012_PharmacoCRRT-study:Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT)
NCT ID: NCT01582360
Last Updated: 2015-10-16
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
640 participants
OBSERVATIONAL
2013-05-31
2018-01-31
Brief Summary
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The effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of filter, filter lifetime etc.
Hypothesis: The risk of incorrect dosage of antiinfectives - to low/ to high- is increased in critically ill patients receiving CRRT. Inadequate plasma concentrations of antiinfectives may contribute to increased mortality in this group.
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Detailed Description
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The effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of filter, filter lifetime etc.
Hypothesis: The risk of incorrect dosage of antiinfectives - to low/ to high- is increased in critically ill patients receiving CRRT. Inadequate plasma concentrations of antiinfectives may contribute to increased mortality in this group.
The antiinfectives to be examined are meropenem, fluconazol, cefotaxim, ciprofloxacin, tazobactam-piperacillin, vancomycin,penicillin,cloxacillin.
Endpoints:
1. Measured plasma concentrations of antiinfectives are sufficient for maximal microbial killing.
2. To identify the most important variability factors for plasma concentrations of antiinfectives in patients receiving CRRT
3. Establish and validate a routine for measurement of vital antiinfectives.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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antiinfectiva: vancomycin
80 patients Completed.
No interventions assigned to this group
antiinfectiva: meropenem
80 patients recruiting
No interventions assigned to this group
antiinfectiva: flukonazol
80 patients
No interventions assigned to this group
antiinfectiva: cefotaxim
80 patients
No interventions assigned to this group
antiinfectiva: benzylpenicilline
80 patients
No interventions assigned to this group
antiinfectiva: tazobactam piperacillin
80 patients recruiting
No interventions assigned to this group
antiinfectiva: cloxacillin
80 patients
No interventions assigned to this group
antiinfectiva: ciprofloxacin
80 patients
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. in need of CRRT
2. without acute kidney failure
2. requirement for antiinfectives\> 72 hrs
3. Age \> 18 yrs
4. signed informed consent
Exclusion Criteria
2. Age \< 18 yrs
18 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Principal Investigators
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Elin Helset, MD PhD
Role: STUDY_CHAIR
Oslo University Hospital
Jan Fr Bugge, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Elizabeth von der Lippe, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Hilde Ma Sporsem, cand pharm
Role: PRINCIPAL_INVESTIGATOR
Sykehusapotekene Oslo
Yvonne Lao, cand pharm
Role: PRINCIPAL_INVESTIGATOR
Sykehusapotekene Oslo
Locations
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Oslo University Hospital
Oslo, , Norway
Countries
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Central Contacts
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Other Identifiers
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2011/10076 (OUSH)
Identifier Type: OTHER
Identifier Source: secondary_id
2011/10076
Identifier Type: -
Identifier Source: org_study_id
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