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

Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT) or Without CRRT

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01582360

Acronym

PharmacoCRRT

Enrollment

640

Registered

2012-04-20

Start date

2013-05-31

Completion date

2018-01-31

Last updated

2015-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Acute Renal Failure, Critically Ill

Keywords

critical illness, pharmacokinetics, CRRT, CVVH, CVVHD, CVVHDF, antiinfectives, antibiotics, minimum inhibitory concentration, bacterial killing, pharmacodynamics, PK/PD index

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Sub-therapeutic levels of measured antiinfectiva	72 hours	Pharmacokinetic/pharmacodynamic index achieved for each antiinfectiva

Secondary

Measure	Time frame	Description
SOFA-score	72 hrs	Sequential organ failure assessment, first 3 days after initiation of therapy
Mortality	90-days	—

Countries

Norway

Contacts

Primary ContactElin Helset, MD PhD

ehj@ous-hf.no+4722119585

Outcome results