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

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

• Registration Number: NCT01582360
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study First Submitted: 2012-04-19
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-20
• Study Start: 2013-05
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-14
• Last Update Posted: 2015-10-16
• Primary Completion: 2017-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 640

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sub-therapeutic levels of measured antiinfectiva	72 hours	Pharmacokinetic/pharmacodynamic index achieved for each antiinfectiva

Secondary Outcome Measures

Name	Time	Method
Mortality	90-days
SOFA-score	72 hrs	Sequential organ failure assessment, first 3 days after initiation of therapy

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway