Tobramycin Administered at the Beginning of Dialysis
Status:
Completed
Trial end date:
2019-12-31
Target enrollment:
Participant gender:
Summary
The purpose of the study is to evaluate whether the administration of a full tobramycin dose
(5 mg/kg) during the first 30 minutes of a hemodialysis session provides favorable
pharmacokinetic parameters in subjects with end-stage renal disease who are suspected or has
been diagnosed with Gram-negative rod-type infection.
It is anticipated that the administration of a single 5 mg/kg dose of tobramycin during the
first 30 minutes of a hemodialysis session will achieve an optimal ratio of maximum
tobramycin concentration to minimal inhibitory concentration (Cmax/CMI) of 8 to 10 while
limiting the accumulation (trough < 2 mg/L before the next hemodialysis session) in end-stage
renal disease subjects requiring intermittent hemodialysis sessions.