NCT01582360

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
• Phase: —
• Study type: Observational
• Enrollment: 640 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critically Ill
• Acute Renal Failure
• Acute Kidney Injury

Timeline

• Start date: 2013-05-01
• Primary completion: 2017-01-01
• Completion: 2018-01-01
• First posted: 2012-04-20
• Last updated: 2015-10-16

Locations

1 site across 1 country: Norway