| Trial ID: | L0798 |
| Source ID: | NCT03904836
|
| Associated Drug: |
Tobramycin
|
| Title: |
Tobramycin Administered at the Beginning of Dialysis
|
| Acronym: |
ESRD
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Dialysis|Renal Failure, Chronic
|
| Interventions: |
DRUG: Tobramycin
|
| Outcome Measures: |
Primary: Ratio of maximum tobramycin concentration to minimal inhibitory concentration, In subjects receiving a single 5 mg/kg tobramycin dose during the first 30 minutes of a hemodialysis session, to determine the proportion of subjects in whom the maximum concentration is greater than or equal to 8 times that of the minimal inhibitory concentration, The timeframe for data collection for this outcome is 48 hours to 72 hours | Secondary: Tobramycin trough level, In subjects receiving a single 5 mg/kg tobramycin dose during the first 30 minutes of a hemodialysis session, to determine the proportion of subjects whose trough concentration of tobramycin is less than or equal to 2 mg / L., The timeframe for data collection for this outcome is 48 hours to 72 hours|Residual clearance, The timeframe for data collection for this outcome is 48 hours to 72 hours|Clearance associated with hemodialysis, The timeframe for data collection for this outcome is 48 hours to 72 hours|Volume of distribution, The timeframe for data collection for this outcome is 48 hours to 72 hours|Total area under the curve, The timeframe for data collection for this outcome is 0 to 48 or 72 hours (depending on time between the two dialysis)|Area under the curve between 0 to 24h after administration, The timeframe for data collection for this outcome is 0 to 24 hours|Tobramycin concentration, Tobramycin concentration 24h, 48h and 72h after administration, The timeframe for data collection for this outcome is 24 hours to 72 hours
|
| Sponsor/Collaborators: |
Sponsor: Maisonneuve-Rosemont Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
11
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2019-01-31
|
| Completion Date: |
2019-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2021-02-26
|
| Locations: |
Maisonneuve-Rosemont Hospital, Montréal, Quebec, H1T 2M4, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT03904836
|
