A Multi-center Randomized Controlled Trial of C-reactive Protein Measurement on Ordering of Blood Cultures in Emergency Department Patients With Sepsis
试验速览
- 阶段
- 不适用
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Blood culture obtained
研究概览
简要总结
Patients with sepsis (2 or more systemic inflammatory response syndrome criteria and suspected infection) assessed in the emergency department have blood cultures obtained to identify potential blood stream infections (BSI). Blood cultures are expensive, sometimes inaccurate, and only positive about 10% of the time in the emergency department.
This study evaluates the effect of physician knowledge of C-reactive protein (CRP) levels on ordering rates of blood cultures in emergency department patients with sepsis. All patients with sepsis will have CRP levels measured using a point-of-care device, prior to blood tests being ordered. Half of participants will have their CRP level available to the emergency physician and half will not. Blood culture ordering rate and safety outcomes will be compared between these two groups.
详细描述
Sepsis, which is defined as the presence of a systemic inflammatory response syndrome (SIRS) in conjunction with a suspected or proven infection, is a significant cause of morbidity and mortality. It is an extremely common presentation in emergency departments. Most sepsis protocols and guidelines call for blood cultures to be obtained in patients with sepsis, in order to identify blood stream infections (BSI) which are usually caused by bacteria in the blood.
Blood cultures obtained in the emergency department are costly, subject to false positive results, and only positive about 10% of the time. Also, they rarely change patient management.
C-reactive protein (CRP) is an inflammatory marker that rises rapidly in the presence of bacterial infections. Because CRP rises as much as 100 times normal levels in the presence of bacterial infections, we have used it successfully to identify patients with sepsis who do not require a blood blood culture, we believe that physicians knowledge of CRP levels can help to guide their decision to order blood cultures.Patients with sepsis (2 or more SIRS criteria and presumed infection) will have their CRP levels measured using a point of care device (Alere Afinion AS100 Analyzer) prior to blood tests being ordered. Patients will be randomized to either have their CRP value shown to the attending physician or not. Rates of blood culture ordering and safety outcomes will then be compared between the two groups.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Emergency department patients with sepsis: Known or presumed infection and 2 or more SIRS criteria: heart rate > 90/minute; respiratory rate > 20/minute; Oral temperature ≥ 38◦ C or < 36◦ C; white blood cell count > 12,000 or < 4,
- •Able to read and understand consent form in English
- •Age 19 years or greater
排除标准
- •Patients presenting with septic shock (systolic blood pressure < 90 mmHG)
- •Patients at risk for endocarditis (previous episodes of endocarditis, injection drug use)
- •Imuno-compromised patients: HIV positive and not on anti-retrovirals; active chemotherapy ; known immune disorder; on immune system modulating drugs, including corticosteroids.
- •indwelling venous catheter (dialysis line, Hickman catheter)
- •hospitalization in previous 2 weeks
- •Surgical procedure in previous 2 weeks
研究组 & 干预措施
CRP value
The patients point of care CRP value is known by the treating physician
干预措施: CRP (Other)
CRP value unknown
The patients point of care CRP value is not known by the treating physician
干预措施: CRP (Other)
结局指标
主要结局
Blood culture obtained
时间窗: 8 hours
Blood cultures ordered (Yes/No)
次要结局
- false positive blood culture(28 days)
- Admission to hospital(7 days)
- 28 day mortality(28 days)
- Antibiotic prescribing(7 days)
- length of stay(28 days)
研究者
Rob Stenstrom
Clinical Assistant Professor
University of British Columbia