Tobramycin Administered at the Beginning of Dialysis

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maisonneuve-Rosemont Hospital
• Treatments: Tobramycin

Criteria

Inclusion Criteria:

• Subjects aged 18 and over;

• Subjects with end-stage renal disease who are on an intermittent hemodialysis program (three times a week, 3-4 hours) at the Hôpital Maisonneuve-Rosemont hemodialysis unit for at least one month;

• Subjects with suspicion or diagnosis of Gram-negative rod-type bacteria infection for which an antibiotic is prescribed;

• Subjects able to consent to the study (consent form read and signed by the subject).

Exclusion Criteria:

• Contraindication or possible medical hazard related to the administration of tobramycin or to any ingredient in the formulation (e.g. sulphites), such as severe allergies or aminoglycoside-reported previous intolerances;

• Variable residual renal function (e.g. acute or transient renal failure requiring occasional hemodialysis sessions, post-renal transplantation);

• Conditions sensitive to the side effects of tobramycin (e.g. history of myasthenia gravis, Parkinson's disease, vestibular or auditory disorder);

• Subjects with impaired volume of distribution (ie, severe burns [> 20%], significant ascites, decompensation for acute heart failure requiring hospitalization, admission to the critical care unit, cystic fibrosis, morbid obesity [dry weight greater than 50% of ideal weight]);

• Pregnant or breastfeeding women;

• Unstable hemodynamic status (risk of not tolerating / completing a 3-4 hour dialysis session);

• Recent treatment with an aminoglycoside (<1 month);

• Participation in another research protocol;

• Inability to give free and informed consent.