2012_PharmacoCRRT-study:Pharmacokinetics of Anti-infectives /Antibiotics in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT)
Information source: Oslo University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Critically Ill; Acute Renal Failure; Acute Kidney Injury
Phase: N/A
Status: Recruiting
Sponsored by: Oslo University Hospital Official(s) and/or principal investigator(s):
Elin Helset, MD PhD, Study Chair, Affiliation: Oslo University Hospital
Jan Fr Bugge, MD PhD, Principal Investigator, Affiliation: Oslo University Hospital
Elizabeth von der Lippe, MD PhD, Principal Investigator, Affiliation: Oslo University Hospital
Hilde Ma Sporsem, cand pharm, Principal Investigator, Affiliation: Sykehusapotekene Oslo
Yvonne Lao, cand pharm, Principal Investigator, Affiliation: Sykehusapotekene Oslo
Overall contact:
Elin Helset, MD PhD, Phone: +4722119585, Email: ehj@ous-hf.no
Summary
The main purpose of the study is to examine if changes in pharmacokinetics of important
antiinfectives in Critically Ill patients in need of continuous renal replacement therapy
(CRRT), causes inadequate concentrations in plasma.
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.
Clinical Details
Official title: Pharmacokinetics of Anti-infectives /Antibiotics in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT) or Without CRRT
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Sub-therapeutic levels of measured antiinfectiva
Secondary outcome: SOFA-scoreMortality
Detailed description:
The main purpose of the study is to examine if changes in pharmacokinetics of important
antiinfectives in Critically Ill patients in need of continuous renal replacement therapy
(CRRT), causes inadequate concentrations in plasma.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients admitted to ICU in need of antiinfectives:
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:
1. Acute or chronic renal failure not in need of CRRT
2. Age < 18 yrs
Locations and Contacts
Elin Helset, MD PhD, Phone: +4722119585, Email: ehj@ous-hf.no
Oslo University Hospital, Oslo, Norway; Recruiting
Elin Helset, MD PhD, Principal Investigator
Jan Fr Bugge, MD PhD, Principal Investigator
Hilde Ma Sporsem, cand pharm, Principal Investigator
Yvonne Lao, cand pharm, Principal Investigator
Kirsti Andersson, MD, Principal Investigator
Additional Information
Starting date: May 2012
Last updated: October 22, 2014
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