Overview

Pharmacokinetics of Colistin in Critically-ill Patients With AKI Who Receive SLED

Status:
Recruiting

Trial end date:
2022-10-31

Target enrollment:
0

Participant gender:
All

Summary

Colistin was developed in the 1960s and preliminary pharmacokinetic studies were performed at that time. Dosing recommendations, on the basis of these pharmacokinetic studies, are listed in the drug's product information. However, there are no optimal dosing recommendations for patients with acute kidney injury who receive sustained low-efficiency dialysis. Furthermore, the science of antibiotic dosing ("pharmacodynamics") has changed significantly since the 1960s and it is quite possible that the dosing recommendations listed in the product information are not optimal. Furthermore, even though physicians refer to "colistin" administration, the only intravenous form of the drug is colistin methanesulfonate (CMS). CMS is converted in the body to colistin. Both CMS and colistin have different pharmacokinetic and antimicrobial activities. For this reason, we, the investigators at the Mahidol university, are performing a pharmacokinetic study of the intravenous CMS/colistin in patients requiring sustained low-efficiency dialysis. Plasma concentrations will be determined around a CMS/colistin dose once the drug has reached steady state. Microbiologic and clinical endpoints will be determined and will be correlated with these concentrations. The measurement of CMS and colistin levels will be determined by a laboratory in Australia.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Mahidol University

Collaborator:

Monash University

Treatments:

Colistin

Criteria

Inclusion Criteria:

- Males or females greater than 18 years of age.

- All patients will remain in the hospital for pharmacokinetic sampling.

- All subjects must be on the medication colistin as part of their standard of care.

- All subjects must be on sustained low-efficiency dialysis

Exclusion Criteria:

- Pregnancy and lactation

- The patients receiving colistin inhalation