Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT) or Without CRRT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Critically Ill
- Sponsor
- Oslo University Hospital
- Enrollment
- 640
- Locations
- 1
- Primary Endpoint
- Sub-therapeutic levels of measured antiinfectiva
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients admitted to ICU in need of antiinfectives:
- •in need of CRRT
- •without acute kidney failure
- •requirement for antiinfectives\> 72 hrs
- •Age \> 18 yrs
- •signed informed consent
Exclusion Criteria
- •Acute or chronic renal failure not in need of CRRT
- •Age \< 18 yrs
Outcomes
Primary Outcomes
Sub-therapeutic levels of measured antiinfectiva
Time Frame: 72 hours
Pharmacokinetic/pharmacodynamic index achieved for each antiinfectiva
Secondary Outcomes
- Mortality(90-days)
- SOFA-score(72 hrs)