Vancomycin
DrugIntravenous
Other names: Vancocin
NCT Number: NCT02945241
Determine if a cystatin C-inclusive vancomycin dosing algorithm improved target trough achievement compared to creatinine clearance-guided vancomycin therapy in critically ill patients.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
This is a prospective, quality improvement study that evaluated critically ill patients initiated on intravenous vancomycin. Between January 2012 through October 2013, vancomycin was dosed at 15-20mg/kg at an interval guided by creatinine clearance using the Cockcroft Gault equation (control arm). Steady state trough concentrations were assessed prior to the 4th dose of a consistent regimen and compared to the individualized target trough range (10-15mg/L or 15-20mg/L) appropriate for the suspected or documented source of infection. Given low overall trough achievement observed with standard care, a quality improvement project was undertaken. After approval by local clinical practice committees with representation from the Division of Infectious Diseases, Pharmacy and Critical Care, a quality improvement project was undertaken to implement a new vancomycin dosing nomogram with dosing intervals based on the Chronic Kidney Disease Epidemiology Collaborative (CKD-EPI) creatinine-cystatin GFR equation, expressed in mL/min. After structured education was provided, the dosing algorithm was rolled out from December 2013 through May 2015 (intervention arm). Steady state target vancomycin trough achievement was compared between study arms with and without adjustment for potential confounders.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous
Other names: Vancocin
Expressed in milliliters per minute
Vancomycin dosing algorithm based on creatinine clearance, expressed in milliliters per minute
Other names: Cockcroft-Gault
Time frame: Baseline
The percentage of initial steady state troughs within the target range.
Time frame: Baseline
Time frame: 7-days
New onset AKI, defined as KDIGO stage II or greater AKI, within 48-hours of and within 7-days of vancomycin initiation
Time frame: 7-days
Treatment failure in patients with confirmed gram-positive infection after at least 48-hours of vancomycin therapy and within 7-days
Time frame: 28-days
New onset of infection within 28-days among patients with confirmed gram-positive infection
Mayo Clinic
Other
Impact of Cystatin-C C-guided Vancomycin Dosing Recommendation on Target Trough Achievement and Clinical Outcomes in Critically Ill Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04171817
Bacterial Infections, Bacterial Infections and Mycoses
Baltimore, Maryland, United States
View Trial DetailsNCT03637400
Cellulitis, Connective Tissue Diseases
Sylmar, California, United States
View Trial DetailsNCT01209234
Methicillin-Resistant Staphylococcus Aureus
Aliso Viejo, California, United States
View Trial DetailsNCT05529173
Infections, Methicillin-Resistant Staphylococcus Aureus
Newark, New Jersey, United States
View Trial Details