2012_PharmacoCRRT-study:Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT)

University of Oslo (UIO)

Status: Unknown

Conditions: Critically Ill; Acute Kidney Injury; Acute Renal Failure

Study type: Observational

Funder types: Other

Identifiers

NCT01582360

2011/10076

2011/10076 (OUSH) (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 640 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

640 participants in 8 patient groups

antiinfectiva: vancomycin

Description:

80 patients Completed.

antiinfectiva: meropenem

Description:

80 patients recruiting

antiinfectiva: flukonazol

Description:

80 patients

antiinfectiva: cefotaxim

Description:

80 patients

antiinfectiva: benzylpenicilline

Description:

80 patients

antiinfectiva: tazobactam piperacillin

Description:

80 patients recruiting

antiinfectiva: cloxacillin

Description:

80 patients

antiinfectiva: ciprofloxacin

Description:

80 patients