Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

STUDY DESIGN: Prospective, monocentric, non-randomized, uncontrolled pharmacokinetic study End-stage renal disease subjects who have been involved in an intermittent hemodialysis program and who have suspected or diagnosed Gram-negative rod-type infection. Pharmacokinetic parameters: Tobramycin concentration analyses done at the beginning of hemodialysis session (before tobramycin administration), 30 minutes after completion of the infusion (will allow us to calculate the peak), during hemodialysis session (additional), at the end of hemodialysis session, between hemodialysis sessions (optional) and just before the next hemodialysis session (will allow us to analyse the trough). RECRUITMENT PROCESS: A systematic daily screening for hemodialysis hospitalized subjects or subjects followed at the outpatient clinic who have a suspicion or diagnosis of Gram-negative rod type infection will be made by the research coordinators. Software routinely used in the clinic at Maisonneuve-Rosemont Hospital (Gesphar, NumeRx, Oacis and Medurge) will be used to ensure the identification of potential subjects. The pharmacists responsible for validation of prescriptions at the pharmacy department will collaborate with the research team to help identifying eligible candidates. An eligibility assessment tool will be used and subjects who meet the inclusion criteria and do not meet any exclusion criteria will be considered as eligible candidates. Thereafter, additional baseline information will be collected from the medical file (e.g. ethnicity) or by questioning the subject. A member of the research team will addressed the eligible subject, will explain the study and present the Information Form and Informed Consent (FIC), that will document informed consent of the subject. DATA COLLECTION: A minimum of four blood samples and a maximum of six blood samples will be collected. The sampling scheme is as follows: at the beginning of hemodialysis session (before tobramycin administration), 30 minutes after completion of the infusion, during hemodialysis session (additional), at the end of hemodialysis session, between hemodialysis sessions (optional) and just before the next hemodialysis session. A member of the research team will provide the tubes to the nursing, will write sampling times and will ship the blood samples to the laboratory. STUDY SAMPLE: Since the objective is to obtain robust pharmacokinetic parameters, the calculation of the sample size aims at a sufficient number of participants to obtain a convergence of facilitated pharmacokinetic parameters, thus obtaining values of coefficients of variation of less than 40%, while maintaining a statistical power of 80%. The calculation uses the variability of the parameters obtained by Veinstein et al. In this study, the residual clearance (Clnhd) is the parameter with the greatest variability (average of 10.4 mL / min with a standard deviation of 6.4 mL / min). Thus, the variability used in calculating the sample size is that of the parameter with the greatest variability, the residual clearance. The sample studied by Veinstein et al. not having the same characteristics as the subjects of the study, the variability could be greater than the reference sample and a safety margin of 30% is added. A total of 12 subjects to be recruited is therefore planned. No correction is applied for losses at the follow-up or withdrawal of consent considering the short duration of the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03904836
Study type Interventional
Source Maisonneuve-Rosemont Hospital
Contact
Status Completed
Phase Phase 1
Start date January 31, 2019
Completion date December 31, 2019

See also
  Status Clinical Trial Phase
Completed NCT05189795 - The Construction of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients
Completed NCT01125202 - Intervention to Reduce Dietary Sodium in Hemodialysis N/A
Completed NCT00806130 - Health Related Quality of Life and Cognitive Function Among Norwegian Dialysis Patients
Completed NCT00730145 - A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis Phase 1
Completed NCT00753116 - Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension Phase 1
Completed NCT05718765 - The Effect of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients N/A
Completed NCT03250715 - Effects of Low Level Laser Therapy on Functional Capacity and DNA Damage of Patients With Chronic Kidney Failure N/A
Completed NCT05469620 - Adaptive Nutrition Therapy in Hemodialysis N/A
Completed NCT03536858 - Social Networks and Renal Education: Promoting Transplantation N/A
Completed NCT00824837 - Study of beta2-Microglobulin Removal by Standard Versus New High Cut-Off Haemodialysis Membrane Phase 1/Phase 2
Completed NCT03403491 - Study of Self-monitoring of Weight & Blood Pressure (Via patientMpower Platform) in Hemodialysis N/A
Terminated NCT02495662 - The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation Phase 2
Completed NCT01179620 - Certoparin in Renal Patients Undergoing Hemodialysis Phase 3
Completed NCT01017276 - A Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal Dialysis Phase 3
Active, not recruiting NCT04466865 - A Communication Tool to Assist Older Adults Facing Dialysis Choices N/A
Recruiting NCT03782519 - Quality of Life of Frail Aged Patients in Incremental Hemodialysis N/A
Recruiting NCT02843334 - Study of the Prevalence of Fabry Disease in French Dialysis Patients N/A
Recruiting NCT02545530 - Transdermal Clonidine in Chronic Hemodialysis Patients N/A
Completed NCT00892749 - Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis Phase 3
Completed NCT00649298 - A Clinical Trial of IntensiVE Dialysis Phase 4