Hematologic Malignancies Clinical Trial
— Hemato-VancoOfficial title:
Optimal Dosing of Vancomycin in an Adult Population of Hemato-oncology: a Nomogram Based on a Bayesian Population Model to Predict Initial Dosage of Vancomycin
This is a single-center prospective pharmacokinetic study. The principal objective is to collect new data among patients with hematologic cancer to develop a Bayesian population pharmacokinetic model and to improve dose adjustment of intravenous vancomycin. Approximately 40 subjects meeting the inclusion and no exclusion criteria will be enrolled in the study. Vancomycin blood concentration will be measured at steady-state at three different moment for each participant : immediately before the infusion, 1 hour after the infusion and during the elimination phase (at 3, 4 or 5 hours after the infusion). This additional vancomycin serum concentration in the elimination phase will be used to estimate more precisely the vancomycin pharmacokinetic parameters in this specific population including the distribution volume and the elimination of the molecule. Ultimately, the purpose of this study is to create a nomogram to predict the optimal initial vancomycin dosing in adult patients with a hematologic cancer.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | October 31, 2021 |
Est. primary completion date | October 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subjects aged 18 and over; - Subjects diagnosed with a hematologic cancer; - Subjects hospitalized at Maisonneuve-Rosemont hospital between February 2021 and August 2021; - Intravenous vancomycin treatment prescribed by a doctor; - Subjects received at least 3 doses of intravenous vancomycin. Exclusion Criteria: - Non-malignant diagnosis (aplastic anemia and rare metabolic diseases); - Subjects admitted to a critical care unit; - End-stage renal disease (GFR < 15 mL/min/1.73m2); - Patients undergoing dialysis/renal replacement therapy; - Acute kidney injury at the moment of the first vancomycin dosage (definition adapted from KDIGO criteria): 1. Increase in serum creatinine by = 26.5 umol/L within 48 hours or 2. Increase in serum creatinine to = 1.5 times baseline within prior 7 days - Pregnant women; - Severely burn patients; - Inability to give free and informed consent. |
Country | Name | City | State |
---|---|---|---|
Canada | Maisonneuve-Rosemont Hospital | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Ciusss de L'Est de l'Île de Montréal |
Canada,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic Parameters : Volume of Distribution | Estimated from vancomycin serum concentrations and patient characteristics | During intravenous vancomycin treatment assessed to 72 hours | |
Primary | Pharmacokinetic Parameters : Vancomycin clearance | Estimated from vancomycin serum concentrations and patient characteristics | During intravenous vancomycin treatment assessed to 72 hours | |
Secondary | Area Under the concentration-time Curve (AUC) | between 0 to 24 hours during vancomycin administration | ||
Secondary | Serum Vancomycin Through Concentration | Vancomycin concentration measured just before the next infusion | 5 minutes before the selected infusion | |
Secondary | Serum Vancomycin Peak Concentration | Vancomycin concentration measured 1 hour after the end of vancomycin infusion | 60 minutes after the end of the infusion | |
Secondary | Serum Vancomycin Elimination Phase Concentration | Vancomycin concentration measured 3 to 5 hours after the end of vancomycin infusion | 3 to 5 hours after the end of the infusion (+/- 30 minutes) |
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