Clinical trial NCT01582360: 2012_PharmacoCRRT-study:Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT)
Official title: Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT) or Without CRRT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critically Ill
Acute Renal Failure
Acute Kidney Injury
Keywords: critical illness
pharmacokinetics
CRRT
CVVH
CVVHD
CVVHDF
antiinfectives
antibiotics
minimum inhibitory concentration
bacterial killing
pharmacodynamics
PK/PD index
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients admitted to the ICU at Oslo University Hospital, in need of treatment with antiinfectives.

Brief 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.

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 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

Primary outcomes:
measure: Sub-therapeutic levels of measured antiinfectiva
timeFrame: 72 hours
Secondary outcomes:
measure: SOFA-score
timeFrame: 72 hrs
measure: Mortality
timeFrame: 90-days
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Elin Helset, MD PhD
role: STUDY_CHAIR
affiliation: Oslo University Hospital
name: Jan Fr Bugge, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Elizabeth von der Lippe, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sykehusapotekene Oslo
name: Hilde Ma Sporsem, cand pharm
role: PRINCIPAL_INVESTIGATOR
affiliation: Sykehusapotekene Oslo
name: Yvonne Lao, cand pharm
role: PRINCIPAL_INVESTIGATOR
References: