NCT02556190

Colistin Pharmacokinetics in Critically Ill Patients During Extended Dialysis

Colistin Pharmacokinetics in Critically Ill Patients With Acute Kidney Injury AKIN III During Extended Dialysis Using the GENIUS Dialysis System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The emergence of multidrug-resistant bacteria has recently renewed interest in colistin. Data on dosing in critically ill patients undergoing extended dialysis are missing. The aim of this study is to determine the pharmacokinetics of colistin during extended dialysis in critically ill patients and to provide dosing guidelines for this drug.

Detailed description

Due to the lack of new antibiotics for the treatment of critically ill patients with multidrug-resistant bacteria, interest in "old" antibiotics like colistin re-emerged. Lastly, colistin is administered more frequently especially in cases of infections due to Pseudomonas aeruginosa, Klebsiella pneumoniae or Acinetobacter baumanii in intensive care units (ICUs) around the world. However, dosing of colistin in critically ill patients undergoing renal replacement therapy is based on scarce data. The aim of this study is to evaluate single and multiple-dose pharmacokinetics of both colistin and its inactive prodrug colistin-methanesulfonate (CMS) in critically ill patients with acute kidney injury (AKI) undergoing extended daily dialysis (EDD). The investigators perform a prospective clinical pharmacokinetic single- and multiple-dose study in the medical and surgical ICUs of the Hannover Medical School. ICU patients with anuric AKI being treated with EDD and receiving i.v. colistin are studied on day 1 and (if possible) on day 5-9 of treatment. A loading dose of 6 Mio IU colistin ís administered 8 hours prior to the EDD session followed by 3 Mio IU every 8 hours. Colistin Plasma concentration levels as well as dialyzer clearance rates are measured at different time points.

Conditions

• Infection Due to Resistant Bacteria
• Acute Kidney Injury

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-09-22
• Last updated: 2016-08-24

Locations

1 site across 1 country: Germany