An interventional study of Additional blood sample in Vancomycin, Hematologic Malignancies and Febrile Neutropenia, sponsored by Ciusss de L'Est de l'Île de Montréal. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-17.
Sponsored by Ciusss de L'Est de l'Île de Montréal · Not applicable, Interventional, and Basic science
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.
STUDY DESIGN:
Prospective, monocentric, pharmacokinetic study.
Adults who have been diagnosed with a hematologic malignancy, are hospitalized at Maisonneuve-Rosemont hospital and received at least 3 doses of intravenous vancomycin.
Pharmacokinetic parameters: Serum vancomycin concentration measured at steady state just before the beginning of the infusion (trough), 1 hour after completion of the infusion (peak) and between 3 to 5 hours after the end of the infusion (additional blood draw during the elimination phase).
RECRUITMENT PROCESS:
A systematic daily screening of hospitalized patients diagnosed with a hematologic cancer will be made by the research team and the pharmacists 7 days a week. An information sheet will be given to all potential eligible patients at their admission. When intravenous vancomycin is prescribed, a member of the research team will explain the study and present the Information and Consent Form (ICF) to the potential participant to obtain his/her official informed consent.
DATA COLLECTION:
Three blood draws will be planned around the fourth or fifth dose of vancomycin and collected by the nursing team. The sampling scheme is as follows: just before the beginning of the infusion (trough), 1 hour after completion of the infusion (peak) and 3, 4 or 5 hours after the end of the infusion (additional blood draw during the elimination phase) according to the assigned time of the participant. The assigned time of the additional blood draw will be randomized at the inclusion of the subject in the study. A member of the research team will provide the tubes to the nurse, will write and save sampling times and will ship the blood samples to the laboratory.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 432 are open to participants now.
This study's planned enrollment of 40 is below the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Ciusss de L'Est de l'Île de Montréal is the lead sponsor of 87 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Acute kidney injury at the moment of the first vancomycin dosage (definition adapted from KDIGO criteria):
Subjects with hematologic cancer who received intravenous vancomycin for a suspected or confirmed infection.
Other: Additional blood sample
Included subjects will provided three blood samples to follow vancomycin concentration
Pharmacokinetic Parameters : Volume of Distribution
Estimated from vancomycin serum concentrations and patient characteristics
Time frame: During intravenous vancomycin treatment assessed to 72 hours
Pharmacokinetic Parameters : Vancomycin clearance
Estimated from vancomycin serum concentrations and patient characteristics
Time frame: During intravenous vancomycin treatment assessed to 72 hours
Area Under the concentration-time Curve (AUC)
Time frame: between 0 to 24 hours during vancomycin administration
Serum Vancomycin Through Concentration
Vancomycin concentration measured just before the next infusion
Time frame: 5 minutes before the selected infusion
Serum Vancomycin Peak Concentration
Vancomycin concentration measured 1 hour after the end of vancomycin infusion
Time frame: 60 minutes after the end of the infusion
Serum Vancomycin Elimination Phase Concentration
Vancomycin concentration measured 3 to 5 hours after the end of vancomycin infusion
Time frame: 3 to 5 hours after the end of the infusion (+/- 30 minutes)
Plan to share: Undecided
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ciusss de L'Est de l'Île de Montréal