BLOOM: Pragmatic Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Proportion of patients screened who qualified for the study
研究概览
简要总结
The goal of this study is to compare two different ways of dosing cefepime, an antibiotic for very sick patients - the usual approach to dosing or a new dosing method. The new dosing method uses only doses that are available in normal care, but choosing between the different doses is based on more information about the patient's body including their kidney function. The primary purpose of this study is to test how easy it is for healthcare professionals to use the new dosing method and how best to conduct the trial. The study will also assess if the new dosing method helps patients recover faster and reduces side effects.
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
- Single (Outcomes Assessor)
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
- •Adults ≥18 years of age
- •Admitted to one of the ICUs at the study center
- •Prescribed cefepime therapy by the care team
排除标准
- •Individuals will be those with a cephalosporin allergy
- •Received >1 dose of cefepime in the 24 hours before ICU admission
- •Transferred from an external hospital without compatible EHR
- •Does not have a cystatin C and a creatinine available for drug dosing
- •Acute kidney injury stage 2 or higher
- •Receiving renal replacement therapy
- •Treated with extracorporeal membrane oxygenation
- •Undergoing molecular adsorbent recirculating therapy at the time of beta-lactam initiation
- •Incarcerated
- •Declined Minnesota research authorization
研究组 & 干预措施
Up-front individualized dosing algorithm
Clinical decision support to encourage use of an individualized cefepime dosing algorithm based on eGFRcr-cysC and weight.
干预措施: Up-front individualized dosing algorithm (Other)
Usual Care
The standard of care group will receive empiric dosing of cefepime, using an institutional antimicrobial guide based on four categories of eGFRcr.
干预措施: Usual Care (Other)
结局指标
主要结局
Proportion of patients screened who qualified for the study
时间窗: 1 year or once the sample size is achieved
Number of patients who quality for the study out of total number of patients screened, reported as a percentage
Distribution of qualified patients across care teams
时间窗: 1 year or once the sample size is achieved
Number of patients from each ICU care team who qualify for the study
Adherence to dosing recommendations
时间窗: 1 year or once the sample size is achieved
Total number of patients randomized to the up-front individualized dosing algorithm who are prescribed the algorithm's recommended dosage
次要结局
- Number of antibiotic-free days(28-days)
- ICU length of stay(1 year)
- Proportion of patients who experience new anti-Pseudomonal beta-lactam resistance(6 months)
- Proportion of patients who experience clinical success(8 days)
- Proportion of patients who experience microbiologic success(8 days)
- Mortality(28-days)