Acute Kidney Injury, Infection Due to Resistant Bacteria
Conditions
Brief 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.
Interventions
None listed
Sponsors
Hannover Medical School
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication for colistin therapy * Acute kidney injury AKIN III with need for renal replacement therapy
Exclusion criteria
* participation in other studies * pregnancy * known colistin allergy or other contraindications for colistin therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colistin elimination during extended dialysis | Participants will be followed for 10 days. Colistin elimination measured by the total drug amount in the collected spent dialysate | Colistin elimination during extended dialysis is measured on day 1 and day 9 after colistin therapy was started. Colistin elimination is measured by the total eliminated drug amount in the total spent dialysate |
Secondary
| Measure | Time frame |
|---|---|
| Colistin dialyzer clearance during extended dialysis | Participants will be followed for 10 days. Dialyzer clearance is calculated after 30 and 180 minutes of extended dialysis on day 1 and day 9 after therapy initiation |
| Colistin peak concentration during extended daily dialysis C(max) | Participants will be followed for 10 days. Colistin concentration is measured at different time points after drug infusion: 0, 0.5, 1, 1.5, 2, 4, 6, 8) on day 1 and day 9 after therapy initiation |
| Colistin trough Level during extended daily dialysis C(max) | Participants will be followed for 10 days. Colistin concentration is measured at different time points after drug infusion: 0, 0.5, 1, 1.5, 2, 4, 6, 8) on day 1 and day 9 after therapy initiation |
Countries
Germany
Outcome results
None listed