Ignite Creation Date:
2024-05-06 @ 4:13 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04911270
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2021-05-24
Brief Title:
Clinical Decision Support Tool for Vancomycin Dosing in Children
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Pharmacokinetic Study to Evaluate the Use of a Novel Clinical Decision Support Tool Lyv in Achieving AUC24MIC 400 in Pediatric Patients on Vancomycin
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the pharmacokinetic and pharmacodynamic dosing properties of intravenous vancomycin in pediatric patients using a novel computer decision support CDS tool called Lyv Dosing will be individualized based on AUC24MIC The results will be compared to matched historical controls
Detailed Description:
This study is a prospective pharmacokinetic study of pediatric patients receiving IV vancomycin at the University of Maryland Patients may be in the Pediatric Intensive Care Unit PICU Neonatal Intensive Care Unit NICU the Intermediate Care Unit IMC or the general pediatric ward
The study design will be comparing historical controls who are retrospective patients that had IV vancomycin dosed based on pharmacists calculations to prospective patients who will have vancomycin dosing based on a clinical decision support tool
Patients requiring IV vancomycin therapy will be selected on the basis of inclusion and exclusion criteria The study procedures will be explained to all patients and written informed consent will be obtained from each subject prior to enrollment
Historical controls will be selected based on the same inclusion and exclusion criteria to minimize bias Full HIPPA waiver will be used for these patients
All patients who consent to enrolling in the study will have vancomycin dosing based on the Clinical Decision Support CDS tool Results will be compared to historical controls Patients must be enrolled within the first 24 hours of initiation of vancomycin
Conventional hospital method- Historical Controls standard of care- retrospective
Data will be collected from patients who were initiated on vancomycin using doses determined by the population parameter calculations These patients will have a minimum of one serum creatinine documented Trough concentrations of vancomycin will typically be collected 30 minutes prior to the 3rd dose Multiple troughs may be collected and will be used for analysis
Clinical Decision Support method intervention group- prospective
Patient information will be entered into the decision support system to calculate vancomycin dose to be initiated in patients after consent is obtained After enrollment into the study the patients serum creatinine level age post-menstrual age if less than one year of age sex weight in kilograms and height in centimeters will be entered into the CDS tool and a suggested dose in mgkg and dosing interval in hours will be recommended All doses recommended by the CDS tool must be approved by the pharmacist If the dosing recommendation was for any reason overridden then it will be recorded in the case report forms The pharmacist will also calculate the AUC24MIC manually The proposed dose by the CDS tool should be within a 20 margin of error of the manually calculated dose The pharmacist will have the option of using the proposed dosing regimen or standard dosing if there is concern with the proposed dose
Once vancomycin has been infused there will be one to two random levels drawn within the first 24 hours and most optimally at least one level drawn prior to the second dose Timing of these blood draws can vary and can be paired with other blood draws that are occurring at the same time This information will then be entered into the CDS tool and the following doses will be calculated Standard trough levels will also be drawn at the discretion of the clinician and will also be used as data points in the CDS tool
These levels will be entered back into the decision support system to determine if the target AUCMIC iswill be attained and if necessary calculate the new dose If a new dose was required another level will again be taken after the newly calculated dose was administered
Subjects will participate in the study for up to 7 days For all subjects the number of blood samples collected for research-related vancomycin level determination will not exceed 5
Serum Samples
Blood samples will be obtained by nursing or medical staff or whoever routinely collects blood samples as part of the standard of care in that unit When possible blood samples obtained as part of routine clinical care for other laboratory assessments will be used in order to minimize the risk to the subjects Samples can be drawn from a peripherally inserted central catheter PICC peripheral IV central line arterial line or a separate blood draw If it is drawn from the same line that was infusing the vancomycin adequate blood waste must occur This includes 3 mL if 2 years old or 5 mL if 2 years old Serum samples will be sent to the University of Maryland laboratory Serum vancomycin levels can only be reported by the laboratory if 5 mgL If it is less than 5 it will be entered as 0 into the CDS
The study design will be comparing historical controls who are retrospective patients that had IV vancomycin dosed based on pharmacists calculations to prospective patients who will have vancomycin dosing based on a clinical decision support tool
Patients requiring IV vancomycin therapy will be selected on the basis of inclusion and exclusion criteria The study procedures will be explained to all patients and written informed consent will be obtained from each subject prior to enrollment
Historical controls will be selected based on the same inclusion and exclusion criteria to minimize bias Full HIPPA waiver will be used for these patients
All patients who consent to enrolling in the study will have vancomycin dosing based on the Clinical Decision Support CDS tool Results will be compared to historical controls Patients must be enrolled within the first 24 hours of initiation of vancomycin
Conventional hospital method- Historical Controls standard of care- retrospective
Data will be collected from patients who were initiated on vancomycin using doses determined by the population parameter calculations These patients will have a minimum of one serum creatinine documented Trough concentrations of vancomycin will typically be collected 30 minutes prior to the 3rd dose Multiple troughs may be collected and will be used for analysis
Clinical Decision Support method intervention group- prospective
Patient information will be entered into the decision support system to calculate vancomycin dose to be initiated in patients after consent is obtained After enrollment into the study the patients serum creatinine level age post-menstrual age if less than one year of age sex weight in kilograms and height in centimeters will be entered into the CDS tool and a suggested dose in mgkg and dosing interval in hours will be recommended All doses recommended by the CDS tool must be approved by the pharmacist If the dosing recommendation was for any reason overridden then it will be recorded in the case report forms The pharmacist will also calculate the AUC24MIC manually The proposed dose by the CDS tool should be within a 20 margin of error of the manually calculated dose The pharmacist will have the option of using the proposed dosing regimen or standard dosing if there is concern with the proposed dose
Once vancomycin has been infused there will be one to two random levels drawn within the first 24 hours and most optimally at least one level drawn prior to the second dose Timing of these blood draws can vary and can be paired with other blood draws that are occurring at the same time This information will then be entered into the CDS tool and the following doses will be calculated Standard trough levels will also be drawn at the discretion of the clinician and will also be used as data points in the CDS tool
These levels will be entered back into the decision support system to determine if the target AUCMIC iswill be attained and if necessary calculate the new dose If a new dose was required another level will again be taken after the newly calculated dose was administered
Subjects will participate in the study for up to 7 days For all subjects the number of blood samples collected for research-related vancomycin level determination will not exceed 5
Serum Samples
Blood samples will be obtained by nursing or medical staff or whoever routinely collects blood samples as part of the standard of care in that unit When possible blood samples obtained as part of routine clinical care for other laboratory assessments will be used in order to minimize the risk to the subjects Samples can be drawn from a peripherally inserted central catheter PICC peripheral IV central line arterial line or a separate blood draw If it is drawn from the same line that was infusing the vancomycin adequate blood waste must occur This includes 3 mL if 2 years old or 5 mL if 2 years old Serum samples will be sent to the University of Maryland laboratory Serum vancomycin levels can only be reported by the laboratory if 5 mgL If it is less than 5 it will be entered as 0 into the CDS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| T32HD087969 | NIH | None | httpsreporternihgovquickSearchT32HD087969 |