Preemptive Empiric Resuscitation Protocol for the Prevention of Disease Progression in the Treatment of Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 5
- 主要终点
- Number of Participants With Worsening Organ System Dysfunction Defined by SOFA Score Increase ≥ 1
研究概览
简要总结
The purpose of this study is to assess the ability of an empiric resuscitation strategy compared to standard care to decrease the incidence of organ failure in normotensive sepsis patients.
详细描述
Sepsis is a challenging and elusive entity with a high mortality rate. As a syndrome, clinicians are challenged to distinguish individuals with systemic infection warranting further interventions from lower severity patients. Sepsis is now recognized as a time-sensitive emergency, as patients stand the best chance for survival when effective therapeutic interventions are delivered as early as possible.
Recent data has shown that in-hospital disease progression from sepsis to septic shock is associated with a higher risk of morbidity and mortality than those with shock on initial presentation. Yet, even when identified and treated with early aggressive interventions, the development of septic shock is still associated with a mortality rate of 25-40%.
Although the presence of sustained arterial hypotension or serum lactate elevation (>4.0 mmol/L) are the currently recommended threshold to define the presence of overt shock and the need for aggressive resuscitation, the investigators have shown that, in patients with systemic infection, a moderate lactate elevation (2.0-3.9 mmol/L) is a common occurrence and an important warning sign for the increased risk of disease progression and death. Sepsis with an elevated lactate between 2.0-3.9, referred to as the "PRE-SHOCK" state, identifies this population of patients at-risk for poor outcome. Current guidelines for sepsis management do not recommend any specific resuscitation measures or therapies for this at-risk population. This study marks the first in a series of investigations addressing the PRE-SHOCK population to further define the adverse events within this cohort and to investigate novel interventions to improve outcomes.
The investigators hypothesize that an early quantitative resuscitation strategy using a protocol-directed IV fluid resuscitation will result in a significant reduction in the development of worsening organ failure (including shock) and mortality compared to standard care.
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
- •Emergency department patient with suspected or confirmed infection as primary reason for admission
- •Serum venous lactate 2.0 - 3.9 mmol/L
- •Hospital admission planned
排除标准
- •Age < 18 years
- •Pregnancy
- •Serum lactate ≥ 4.0 mmol/L
- •Any vasopressor or inotrope requirement
- •Mechanical ventilation or non-invasive positive pressure ventilation
- •Chronic end-stage renal disease requiring hemodialysis
- •Pulmonary edema as diagnosed by the primary care team
- •Requirement for surgery within the treatment protocol timeframe
- •Inability to obtain informed consent from subject or surrogate
- •Patient to receive comfort measures only
研究组 & 干预措施
Interventional arm
Protocolized empiric resuscitation delivering weight-based intravenous fluid resuscitation targeting lactate normalization
干预措施: Intravenous fluid (Drug)
结局指标
主要结局
Number of Participants With Worsening Organ System Dysfunction Defined by SOFA Score Increase ≥ 1
时间窗: 72 hours
Development of worsening organ failure defined by the Sequential Organ Failure Assessment (SOFA) score. The SOFA score defines the presence and severity of dysfunction within 6 organ systems (cardiovascular, respiratory, coagulation, liver, renal, and nervous system) with a value of "0" for assigned to normal function to a maximum value of "4" for severe dysfunction in each of the organ systems. Each component of the SOFA score is added together, ranging from "0" indicating no organ dysfunction in any of the 6 organ systems, to "24" indicating maximal organ dysfunction across all 6 organ systems. Within this trial, the occurrence of organ failure was defined by any increase in the total SOFA score by ≥ 1 point over the first 72 hours after randomization.
次要结局
- Number of Participants With Experiencing Complications Related to Intravascular Volume Overload(12 hours following treatment initiation)
- In-hospital Mortality(In-hospital discharge or up to maximum 30 days)