Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Number of Participants Who Achieved the Target Vancomycin Concentration
研究概览
简要总结
Vancomycin is an essential antimicrobial which is frequently used in the ICU for suspected methicillin-resistant Staphylococcus aureus (MRSA) infection. Therefore, it is vital to optimize the dosing of vancomycin for this critically ill population. The most efficacious method of administering vancomycin is debated in the literature. Since vancomycin is associated with slow bactericidal activity, it is important to closely monitor serum concentrations so as to achieve early target serum concentration, particularly when treating aggressive S. aureus infections. One study has shown that vancomycin infused continuously may enable faster and more consistent achievement of a therapeutic serum concentration when compared to intermittent infusion. A faster achievement in the goal serum vancomycin concentration would be a protective factor for intensive care unit mortality in patients with MRSA infection.
Currently in the surgical ICU (SICU) of our institute, vancomycin is administered based on a vancomycin dosing nomogram. Less than fifty percent of the ICU patients following this nomogram achieved target vancomycin concentration of 15 after 24 hours. To better achieve target vancomycin concentration in 24 hours, we developed a new vancomycin dosing nomogram with a continuous infusion. The aim is to determine which of the two dosing nomogram is more efficient and safer for SICU patients.
详细描述
Early administration of effective antibiotics is the cornerstone of management in septic patients; however, altered pharmacokinetics in critically ill patients has lead to subtherapeutic antibiotic exposure with standard antibiotic dosing and administration. This is further evidenced by low therapeutic target achievement with our intermittent vancomycin dosing nomogram. Administering vancomycin by continuous infusions may lead to achieving a therapeutic concentration and AUC24 more quickly than the administration by intermittent infusions as well as provide a more consistent concentration throughout the dosing period. Therefore, a new vancomycin continuous infusion nomogram was developed to increase the achievement of a goal vancomycin concentration within 24 hours.
We hypothesized that vancomycin administered as continuous infusion would achieve the therapeutic target sooner and more consistently than when administered as an intermittent infusion in critically ill surgical patients. The aims of this study were to determine the dosing differences between continuous (CIV) and intermittent (IIV) dosing in critically ill surgical intensive care unit (SICU) patients with preserved renal function and whether calculated Cockcroft-Gault Creatinine Clearance (CG CrCL) or measured creatinine clearance (CrCL) is a better predictor of vancomycin clearance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and non-pregnant female > 18 years of age admitted to Surgical ICUs with suspected infection
- •Calculated creatinine clearance > 60ml/min
排除标准
- •Age < 18 years
- •Allergic to vancomycin
- •Calculated creatinine clearance < 60ml/min
- •Vancomycin administration more than 8 hour and less than 24 hour prior to study enrollment
- •Anticipated vancomycin treatment less than 2 days for surgical prophylaxis
研究组 & 干预措施
Vancomycin with continuous infusion
24 hours continuous infusion
干预措施: Vancomycin continuous infusion (Drug)
Vancomycin with intermittent dose interval
infusion rate 1000mg/hr
干预措施: Vancomycin intermittent dosing interval (Drug)
结局指标
主要结局
Number of Participants Who Achieved the Target Vancomycin Concentration
时间窗: 24 hours
The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV
次要结局
- Time Required to Reach the Therapeutic Levels(as long as participants are receiving Vancomycin (mean (SD) 9 (3.8) days for continuous, 8.4 (4.1) days for intermittent))
- Vancomycin Concentration at 24 Hours(24 hours)
研究者
Hsin Jung Lin
PharmD
Massachusetts General Hospital