Improving Sepsis Diagnosis and Treatment: Simplified Severe Sepsis Protocol (SSSP)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- In-hospital all cause mortality
研究概览
简要总结
This study is a randomized control trial assessing the impact of a simple evidence-based protocol for the treatment severe sepsis in Zambia. The intervention protocol consists of a scheduled fluid regimen, early blood culture and antibiotics, and dopamine and blood transfusion when necessary. It is hypothesized that the protocol will significantly decrease in-hospital mortality in patients with severe sepsis.
详细描述
In recent years, evidence-based protocols of bundled therapies have improved survival of severe sepsis in developed countries. However, in sub-Saharan Africa, simple therapies such as IV fluids and early antibiotics are frequently under-utilized. Furthermore, although tuberculosis is a common cause of severe sepsis in the region, accurate and timely diagnosis of tuberculosis-associated severe sepsis remains elusive.
The aims of this study are (1) To assess the impact on survival of a simple evidence-based protocol for severe sepsis, (2) To evaluate the cost of implementation for a simplified severe sepsis protocol (3) To develop a clinical diagnostic score for identifying tuberculosis in HIV positive patients with severe sepsis (4) To assess the performance of the Xpert TB/RIF rapid PCR system for diagnosing tuberculosis in HIV positive patients with severe sepsis.
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 (Participant)
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
- •Age 18 or older
- •Suspected infection
- •2 or more of SIRS criteria:
- •Heart rate >90/min
- •Respiratory rate >20/min
- •Temperature >= 38° C or <= 36° C
- •White blood count > 12,000 or < 4,000/µL
- •1 or more of the following signs of end-organ dysfunction
- •Systolic blood pressure < 90 mm Hg
- •Mean arterial blood pressure (MAP) < 65 mm Hg
- •Confusion/altered mentation
- •Urine output < 0.5 mL/kg/hr
- •Creatinine increase > 0.5 mg/dL
- •Creatinine > 0.5 mg/dL above upper limit of normal
- •Platelet < 100x109/L
- •Respiratory rate > 40/min
排除标准
- •Need for urgent surgery
结局指标
主要结局
In-hospital all cause mortality
时间窗: During hospitalization, expected average 14 days
次要结局
- 28-day all cause mortality adjusted for baseline illness severity(28-day)
- Treatment cost per patient(During hospitalization, expected average 14 days)
- In-hospital all cause mortality adjusted for illness severity(During hospitalization, expected average 14 days)
- 28-day all-cause mortality(28-day)
- Cumulative adverse events(During hospitalization, expected average 14 days)
- Antibiotic changed due to culture results(During hospitalization, expected average 14 days)