Comparing continuous and intermittent vancomycin infusion methods
A Randomized Clinical Trial of Continuous vs. Intermittent Infusion Vancomycin: Effects on Measured GFR and Kidney Injury Biomarkers
PHASE4 · University of Kentucky · NCT05823116
This study tests whether giving vancomycin continuously or in intervals helps hospitalized adults while keeping an eye on their kidney health.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kentucky (other) |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT05823116 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves hospitalized adult patients who have been prescribed vancomycin. Participants will be randomly assigned to receive the medication either through continuous or intermittent infusion. The study aims to monitor kidney function and potential injury by measuring glomerular filtration rate (GFR) and adjusting dosages as needed to maintain consistent vancomycin exposure. A precision dosing platform will be utilized to ensure optimal dosing for both infusion strategies.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults aged 18 and older who are prescribed vancomycin and can provide informed consent.
Not a fit: Patients with chronic kidney disease, end-stage kidney disease, or those experiencing acute kidney injury may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney safety and efficacy in vancomycin administration for hospitalized patients.
How similar studies have performed: Other studies have explored vancomycin infusion methods, but this specific comparison of continuous versus intermittent infusion is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 18 years of age * Hospitalized at University of Kentucky on a medical service (internal medicine or medical intensive care) * Prescribed ≥ 2 doses of vancomycin per treating physician * Be able to provide written, informed consent, or have a legally authorized representative (LAR) responsible for their care able to provide written, informed consent. Exclusion Criteria: * Chronic kidney disease (documented or prior to admission estimated GFR (eGFR) \<60 ml/min/1.73m2 using non-race-based creatinine GFR equation) * End stage kidney disease * Stage 1 or higher AKI per Kidney Disease: Improving Global Outcomes (KDIGO) classification (serum creatinine increase ≥ 0.3 mg/dl or 1.5-1.9 times baseline; urine output \< 0.5 ml/kg/hr for 6-12 hours) * Greater than 2 doses of vancomycin within the last 72 hours * Allergy to iohexol * Uroepithelial tumors * Pregnancy * Prisoner
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (RECRUITING)
Study contacts
- Principal investigator: Aaron M Cook, PharmD — University of Kentucky
- Study coordinator: Aaron M Cook, PharmD
- Email: aaron.cook@uky.edu
- Phone: 8593239258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vancomycin, Infusion, Adverse Effect, Acute Kidney Injury