Simplified Severe Sepsis Protocol-2 (SSSP-2): A Randomized Controlled Trial of a Bundled Intervention for Severe Sepsis at the University Teaching Hospital in Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 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 with hypotension in Zambia. This is a follow-up study to the Simplified Severe Sepsis Protocol (SSSP) study. 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 and hypotension.
详细描述
In recent years, evidence-based protocols of bundled therapies have improved survival of severe sepsis in developed countries. In sub-Saharan Africa, simple therapies such as IV fluids and early antibiotics are frequently under-utilized. Studies of fluid interventions in the region, however, have demonstrated conflicting results. Outcomes in septic patients may be further affected by delays in the diagnosis of tuberculosis-associated severe sepsis.
The aims of this study are (1) To assess the impact on survival of a simple evidence-based protocol for severe sepsis with hypotensionor septic shock, (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, and (4) To assess the performance of the Xpert TB/RIF rapid PCR system and urine lipoarabinomannan assay 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
- •infection suspected by the treating physician
- •2 or more of the following 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 of the following:
- •Systolic blood pressure (SBP) ≤ 90 mm Hg
- •Mean arterial blood pressure (MAP) ≤ 65 mm Hg
排除标准
- •Gastrointestinal bleed in the absence of fever
- •Need for immediate surgery
- •Respiratory rate greater than 40/min with oxygen saturation less than 90%
- •Suspected congestive heart failure exacerbation
- •End-stage renal disease
- •Raised jugular venous pressure (JVP) at baseline
- •Currently incarcerated
研究组 & 干预措施
Simplified Severe Sepsis Protocol
This protocol consists of an early aggressive fluid strategy, early blood cultures and antibiotics, and, when appropriate, blood transfusion and titratable dopamine. Monitoring is based on physical exam findings. Antibiotics are specified by the admitting doctors.
干预措施: Simplified severe sepsis protocol (Other)
Usual care
Patients are managed according to admitting doctors' orders. Blood cultures are drawn in all patients. Antibiotics are specified by the admitting doctors.
干预措施: Usual care (Other)
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(28-day)
- Antibiotic changed due to culture results(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 adjusted for baseline illness severity(28-day)
- Cumulative adverse events(During hospitalization, expected average 14 days)
- Treatment cost per patient(During hospitalization, expected average 14 days)